Quality Assurance Process Validation

RESUME

Dr. T. Vijaya Bhaskara Reddy

Mobile: +91-722*******, 722********

Residence: +91-994*******

Email: *************@*****.***

https://in.linedin.com/pub/dr-t-vijay-reddy/a3/8a0/764

OBJECTIVE:

●A responsible and challenging position in a reputed organization that would enable me to augment my already acquired knowledge base, bring to the forefront my skills and offer opportunities for growth and career advancement par excellence, essentially based on my achievements.

●Having UK QP Declaration as an Auditor and faced so many Vendor qualification audits & Regulatory audits i.e. USFDA, MHRA, EU, Health Canada, ANVISA-Brazil, Zazibona, Germany and Ukraine.

PROFESSIONAL EXPERIENCE:

●Currently working as AGM, Quality Assurance (Regulatory compliance) at Natco Pharma, Hyderabad.

Duration: 06-05-2023 to till date.

Responsible for Handling of Regulatory Inspections, Customer Audits and Closing of Audit & Compliance Reports. Handling of Quality Review meetings & Quality Agreements

Responsible for Planning, execution of the self-inspection program by coordinating with

relevant departments for the initiation of CAPA(s) and close the Compliance Reports.

Responsible for supporting of Regulatory Department Dossier Fillings (relevant to Process Validations, Risk Assessments and Annual Product Reviews).

Responsible for review of Process Validations (Commercials and Exhibit/Submission), Hold Time Study (Product and Equipment), Cleaning Validations Protocols and Reports.

Review and compliance of Product Quality Risk Assessment related to Products, Equipment and Utilities.

Monitoring and Review of Regulatory submissions documents i.e Specifications, STP’s, Batch records, Analytical validation documents, Stability reports and Process validation.

Monitoring and reviewing of Training, Documentation, Data integrity issues and other Investigations.

● Previously worked as SME at HCL Technologies (Novonordisk), Bengaluru, Karnataka.

Duration: 25-11-2019 to 03-05-2023.

Having extensive experience ensuring quality in regulated manufacturing environments for Pharmaceutical Formulations (Injectables). Participates in Quality & Regulatory Data Quality initiatives and supports for Project completion.

Review and compile ANDA dossier for US and EU as per agency requirements.

Timely compilation of quality response to queries i.e IR,DRL and CRL, assessment reports.

Preparation, Review and monitoring of Process validation, cleaning validation, Quality Management System. SOP for SOP, OOT, CAPA, Incidents, Deviations, Change control etc…

21 CFR part 11,210 & 211 compliance

●Previously worked as Regulatory Affairs Sr. Manager at Strides-Vivimed Pharma, Chennai, Tamilnadu.

Duration: 25-01-2019 to 16-11-2019.

Preparation and Review of ANDA Dossier documents i.e Batch records, validation documents etc.. as per eCTD for US Finalize documents pre-submission & post-authorization.

Monitoring and review of Analytical validation, Process validation and cleaning validation

Preparation, Review and monitoring of Quality Management System. SOP for SOP, OOS, OOT, CAPA, Incidents, Deviations, Change control, Preventive maintenance, Annual Product Reviews, Validations etc…

PADER(ICSR) review and submission as per 21 CFR 314.80; Annual report review and submission as per 21 CFR 314.70.

Artwork; Review of labeling documents including labels,cartons,foil,package insets,SmPC,SPL for submission and commercial to ensure that the artwork complies with RLD and regional requirements.

●Previously working as Manager at Pfizer facility under Quality In Core Consultancy, Quality Assurance Manager, Chennai, Tamilnadu.

Duration: 16-07-2018 to Jan-2019.

Monitoring & Reviewing CPV (Continued process verification) for all Injections Products and ensure statistical fitness for all products.

Monitoring & Reviewing Process validation and cleaning validation.

21 CFR part 11,210 & 211 compliance

Monitoring and review of Process validation (Process Design Documents, Process Qualification Documents and Continued Process Verification Documents).

●Previously worked as Manager at Optimus Pharma Private Limited, QA Department, Hyderabad, Telangana.

Duration: 14-12-2017 to 30-06-2018.

Monitoring & Review of Different kind of pharmaceutical Dosage forms like Tablets, Capsules and Ointments Product Development Reports (PDR) & Analytical method development reports and their Validations as per QbD. monitoring and review of Process validation (Process Design Documents, Process Qualification Documents and Continued Process Verification Documents), Cleaning validation (PDE, MACO and 10ppm), Water Validation, Micro Validations, Stability Monitoring, and GAMP5.

Preparation, Review and monitoring of Quality Management System. SOP for SOP, OOS, OOT, CAPA, Incidents, Deviations, Change control, Preventive maintenance, Annual Product Reviews, Validations etc…

●Previously worked as a Manager at Vivimed labs, QA, Hyderabad, Telangana.

Duration: 01-06-2017 to 13-12-2017.

Job Profile: Corporate Project & Quality Management with Lean management principles in Product life cycle, Audits,21 CFR part 11,210,211&820 compliance, Eudralex volume 4 compliance, PIC/S,WHO Guidelines Compliance.

Monitoring and review of Process validation (Process Design Documents, Process Qualification Documents and Continued Process Verification Documents), Cleaning validation (PDE, MACO and 10ppm),Analytical method Validations, Water Validation, Micro Validations, Stability Monitoring, and GAMP5. Training has been given for CGMP, GDP, Audit Trails, Data Integrity, Six sigma, Lean management and GLP.

●Previously worked as an Asst. Manager at BnS Group, RA/QA Department, Vadodara, Gujarat.

Duration: 01-04-2015 to 30-05-2017.

Job Profile:

Monitoring & Review of Different kind of pharmaceutical Dosage forms like Tablets, Capsules, Solutions and Suspensions Product Development Reports (PDR) as per QbD. Having Good Knowledge on ICH Quality Guidelines.

Monitoring & Review of Analytical method validation like Assay, Dissolution, Related Substance and Identification of protocols and reports.

Monitoring & Review of Different kind of Process Validation documents like Process Design Documents, Process Qualification Documents and Continued Process Verification Documents while the preparation of Scale-up and Exhibit Batches.

Review and monitoring of Quality management system. SOP for SOP, OOS, OOT, CAPA, Incidents, Deviations, Change control, Preventive maintenance, Annual Product Reviews, Validations, water validations and Stability Management etc…

Monitoring & Review of Instruments, Systems and Equipment Qualifications like DQ,IQ,OQ and PQ.

Identification, selection and Authorization of Contract Manufacturing Organization(CMO) for Scale-up and Exhibit batches based on Regulatory approvals, batch sizes, Equipment capacities, utilities and Organization policy.

●Previously worked as an Asst. Manager at Finoso Pharma private Limited, QA Department, Alexandria Knowledge Park, Turkapally, Hyderabad.

Duration: 08-08-2012 To 31-03-2015.

Job Profile:

Played an active role in product pipeline selection, feasibility and product life cycle management. To ensure compliance to regulatory and Quality Management System requirements. Managed entire product development program from molecule selection, development strategy, risk assessment analysis, Product Development Report (QbD), Execution of Validations, Preparation of Specifications and Testing procedures, Analytical Method Development, Analytical Method validation, Analytical Method Transfer and regulatory filings of generic products.

●Previously worked as a Junior Manager at Dr.Reddy’s Laboratories Limited, Quality Assurance Department, Bachupally, Hyderabad.

Duration: 15-02-2010 To 27-07-2012.

Job Profile: Monitored all IPQA activities like Dispensing, Manufacturing, Filling and Packing in Production department. Monitoring Validation batches and their reports for compliance. Collection of Control, Validation, Stability and Reserve samples. Tracking of self inspection and internal audits as per the audit schedule. Review of self inspection audit reports for compliance to SOP requirements. Logging of CAPA actions of the site self inspection audits. Perform allotted self inspection & internal audits as per schedule & track the CAPAs for completion. Giving line clearance and carrying out In-process checks and updating batch records. Implementations of change control, Incident, Deviation and their Disposition. Coordinating to all the Internal, External and Regulatory Audits. Execution of Transport worthiness studies and ensuring the Data loggers as per consignment. Performing self inspections and ensuring compilation of non-compliances.

●Previously worked as an executive in Granules India limited, Quality Assurance Department. Hyderabad.

Duration: May 2008 to 09-02-2010.

Job Profile: Monitoring all IPQA activities like Dispensing, Manufacturing, Filling and Packing of different pharmaceutical products.

EDUCATIONAL PROFILE:

●Ph.D from Acharya Nagarjuna University.

(“Application of UV Spectrophotometric, FTIR, RP-HPLC, UPLC and LC/MS/MS techniques for the analysis of selected drugs in bulk and pharmaceutical formulations”)

●M. Pharmacy (Pharmaceutical Chemistry) from Annamalai University, Chidambaram.

●B. Pharmacy J.N.T.University, Hyderabad.

LIST OF RESEARCH PUBLICATIONS:

●“A Stability indicating RP-HPLC method for the determination of Amitriptyline Hydrochloride in pure and dosage forms”, Journal of pharmacy research, 2012, 5(7), p: 3896-3899.

●“Development and Validation of Stability indicating reverse phase liquid chromatographic method for the assay of Famotidine in bulk and formulations”, Rasayan Journal of Chemistry, 2012, 5(2), p: 250-255.

●“Development and Validation of HPLC Method for the estimation of Lamotrigine in bulk and pharmaceutical formulations”, Journal of Chemistry a Hindawai publication, volume 2013, Article ID846170, p: 1-4.

● “Validated RP-HPLC Method for the Determination of Mycophenolate Mofetil in Tablet Dosage Forms”, Asian Journal of Chemistry; Vol. 25, No. 9 (2013), p: 4788-4790.

●“Optimized and validated RP-UPLC Method for the study of forced degradation and determination of mycophenolate mofetil in tablet dosage forms”, Analytical chemistry: An Indian Journal, Manuscript Information of: An944211904, p: 1-10.

●“RP-HPLC Method for the estimation of Nitroxazepine Hydrochloride in Pharmaceutical Dosage forms”,International journal of Applied Biology and Pharmaceutical Technology;Volume :I,Issue:3(2010),Pages:1181-1187.

●“Validation of new Spectrophotometric Methods for Quantitative Determination of 7-ADCA IN Pharmaceutical Formulation”, International journal of Applied Biology and Pharmaceutical Technology; Volume: I, Issue: 3(2010), Pages: 1194-1201.

●“Development of stability indicating liquid chromatography-mass tandem spectrometric method for the estimation of mycophenolate mofetil in bulk and pharmaceutical formulations”;Journal of Pharmacy Research an ELSEVIER publication;Volume:7;Issue:7;July 2013;Pages:640-646.

●“Optimized and validated stability indicating RP-UPLC method for the determination of famotidine in pharmaceutical formulations”; Journal of Pharmacy Research an ELSEVIER publication;Volume:6;Issue:8;Aug 2013;Pages:865-869.

●“Stability Indicating Reversed Phase UPLC Method for the Assay of Lamotrigine in Tablet Dosage Form”; journal of global trends in pharmaceutical sciences an ELSEVIER product; Volume: 4; Issue: 4; pages: 1346-1355.

●“Spectrophotometric determination of Doripenem in bulk and pharmaceutical formulations by oxidation and azo dye reactions”; Analytical chemistry an Indian journal; Volume: 14; Issue: 2; pages: 43-48.

●“FTIR Spectroscopic Method for the determination of Famotidine in pure and pharmaceutical formulations”; Analytical chemistry an Indian journal; Volume: 14; Issue: 2; pages: 61-66.

●“Derivative spectrophotometric determination of Naratriptan Hydrochloride in pure and dosage forms by Oxidative coupling and Condensation Reactions”; journal of global trends in pharmaceutical sciences an ELSEVIER product; Volume: 5; Issue: 1; pages: 1410-1418.

●“Assay of Famotidine in API and dosage forms by UV direct and UV derivative spectrophotometric methods";Der pharmacia sinica; Palagia research library; Volume: 5; Issue: 1; pages: 57-65.

●“UV Spectrophotometric and its derivative methods for the determination of Lamotrigine in pure and dosage forms"; journal of global trends in pharmaceutical sciences an ELSEVIER product; Volume: 5; Issue: 2; pages: 1628-1633.

●“Formulation and evaluation of Tolterodine Tartrate Extended Release Capsules using multiparticulate drug delivery system” ; journal of global trends in pharmaceutical sciences an ELSEVIER product; Volume: 5; Issue: 2; pages: 1692-1698.

●“Formulation and evaluation of Darifenacin Hydrobromide Extended Release Formulation using Reservoir Drug Delivery System”; journal of global trends in pharmaceutical sciences an ELSEVIER product; Volume: 5; Issue: 2; pages: 1699-1705.

●“UV direct and UV derivative spectrophotometric method for the determination of Mycophenolate Mofetil in pure and Dosage forms "; Analytical chemistry an Indian journal. Volume: 14; Issue: 8; Pages: 296-301.

●“UV direct and UV Derivative Spectrophotometric methods for the Determination of Amitriptyline Hydrochloride in pure and Dosage Forms”; Der pharmacia sinica; Palagia research library; Volume: 5; Issue: 3; Pages: 9-17.

●“Stability indicating validated Related Substance UFLC method & Alkali Degradation Impurities Characterized by LCMS for Irbesartan in bulk and pharmaceutical Formulation product”; journal of global trends in pharmaceutical sciences an ELSEVIER product; Volume: 5; Issue: 3; Pages: 1905-1911.

●“FTIR Spectroscopic Method for the determination of Lamotrigine in pure and pharmaceutical formulations “; International journal of chromatographic technologies; Volume: 1; Issue: 1; Pages: 12-18.

●“FTIR Spectroscopic Method for the determination of Amitriptyline Hydrochloride in pure and pharmaceutical Drug Substance”; International journal of chromatographic technologies; Volume: 1; Issue: 1; Pages: 19-26.

●“Development of stability indicating RP-UPLC method for the determination of Amitriptyline Hydrochloride in bulk and its pharmaceutical formulations "; Analytical chemistry an Indian journal. Volume: 15; Issue: 2.

●‘’ Stability indicating RP-UPLC method for assay of emtricitabine and tenofovir disoproxil fumarate in bulk and dosage forms’’; American journal of analytical chemistry, Volume: 6, 2015, Pages: 807-821.

●“Stability indicating RP-HPLC method for assay of emtricitabine and tenofovir disoproxil fumarate in bulk and dosage forms’’; International journal of pharmacy and pharmaceutical sciences; 2015;Volume 7; Issue 9; Pages: 390-398.

●“Assay and stability studies of cobicistat and atazanavir sulphate in combined dosage form by RP-UPLC method”; Der Pharmacia Lettre; 2016; Volume 8; Issue 2; Pages: 435-446.

●“RP-HPLC method development for the assay and degradation study of Cobicistat and Atazanavir sulphate in bulk and combined dosage form“; European journal of biomedical and pharmaceutical sciences;2016; Volume 3; Issue 5; Pages: 450-461.

●“Using Chitosan and Natural polymer mixtures as release retarding polymers in sustained release matrix tablets of Venlafaxine Hcl”;Journal of global trends in Pharmaceutical sciences; Volume 7;Issue 2; Pages: 3233-3241.

●“Simultaneous estimation of Cobicistat and Atazanavir Sulphate in bulk and combined dosage form by UV-Spectrophotometric method”;World Journal of Pharmaceutical Research; Volume 5;Issue 10; Pages: 914-932.

●“Stability indicating UV-Spectrophotometric method for simultaneous determination of Emtricitabine and Tenofovir desoproxil fumerate in Truvada’; Der Pharmacia Lettre; Volume 8;Issue 17; Pages: 185-195.

●“Validated Reversed Phase HPLC Method for Assay and Degradation Studies of Lamivudine, Abacavir Sulphate And Dolutegravir In Combined Dosage Form”;International journal of education and applied research; volume 6;Issue 2;Pages:86-95.

●“Simultaneous determination of Emtricitabine and Tenofovir desoproxil fumarate in Truvuda BY Derivative spectroscopy”; Asian journal of chemistry; volume 29; Issue 5; Pages:1069-1075.

●“Optimized and validated Stability indicating RP-HPLC method for the determination of Pristinamycin in bulk and pharmaceutical formulation”; journal of global trends in pharmaceutical sciences an ELSEVIER product; Volume: 10; Issue: 2; Pages: 6105-6112

●“Optimized and validated Stability indicating RP-HPLC method for the determination of Telmisartan in bulk and pharmaceutical formulation”; International journal of pharmacy and biological sciences; Volume: 9(2019); Issue: 2; Pages: 780-786.

TRAININGS:

● “Prepare your electronic lab data to face Regulatory bodies” by Waters on 12-09-2013

●“Best practices in Aquity UPLC to achieve increase productivity” by Waters on 28-03-2014.

●“Six sigma white belt on line course” certification has been awarded on 3rd August 2017 by Udemy.

●“Lean six sigma premier online course” certification has been awarded on 7th August 2017 by Udemy.

●“Quality management essentials simplified online course” certification has been awarded on 7th August 2017 by Udemy.

●“Six sigma yellow belt; A beginner’s guide to six sigma online course” certification has been awarded on 7th August 2017 by Udemy.

●Data integrity Observations and Waters services by Waters on 06-06-2018.

LIST OF POSTER PRESENTATIONS:

“ANALYSIS OF BULK DRUGS AND PHARMACEUTICAL FORMULATIONS BY ADOPTING SOME MODERN INSTRUMENTAL METHODS” in National poster symposium;” The royal society of chemistry (London) & centre for chemical sciences and technology, IST, JNTUH”, 24-12-2014.

MEMBERSHIPS:

●Advisory Editorial Board Member for Journal of Global trends in Pharmaceutical Sciences

●Editorial Board Member for International journal of chromatographic Technologies.

●Advisory Board Member for European journal of Biomedical and Pharmaceutical Sciences.

PERSONEL DETAILES:

Full name : Dr. T. Vijaya Bhaskara Reddy

Father’s name : T.G. Pratap Reddy

Sex : Male

Marital status : Married

Languages Known : English, Telugu, Hindi and Tamil.

DECLARATION:

I have declared that all the above furnished information is true and correct to the best of my knowledge and belief.

(Dr. T. Vijaya Bhaskara Reddy)

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