Manager Quality Assurance

CURRICULUM VITAE

DEVENDRA. B. SINGH,

NEAR THE POST OF ANTALIA

TALUKA-GANDEVI

DIST-NAVSARI

VIA-BILIMORA

396325(Gujarat)

Call me at:074********,094********

Mail me at: Email ID: *********@*****.***

PROFESSIONAL PROFILE:

An overview: From Aug 2000 to till date, total arround 16 years experience in QA department.

PRESENT WORK EXPERIENCE:

Company Name: NEON GROUP OF COMPANY (AXIOMMAX PHARMA) in RUDRAPUR (UP)

Period : Since MAY 2016 to till date.

Designation : Working as “Manager –QA.”

ACADEMIC PROFILE:

M.Sc with (Chemistry) in MKU, Tamilnadu

B.Sc with (Chemistry) in SOUTH Gujarat University

COMPANY PROFILE:

NEON GROUP OF COMPANY (AXIOMMAX PHARMA) is a manufacture of multidosage forms like Injection, Tablet. Oitments, jell etc

Present Job Responsibilities:

Over all compliance for Quality Assurance function at site.

Plan & provide support to manufacturing activities as per Quality Management System (QMS) / GMP guidelines.

Ensure the preparedness of system / records for external inspection / audits from regulatory agencies / certifying agencies.

Internal audits / Self Inspection are carried out for compliance & represent the major finding to management for improvement of the systems.

Ensure the in-process compliance in Granulation. Compression, Coating, Capsule, Injectable, Oitments section, packing & day to day shop floor activity.

Responsible to establish, validate, upgrade & implement the Quality Management system.

To ensure that the response to regulatory audit observations with in stipulated time frame.

To ensure that approved manuals, Site Master File, Validation Master Plan, Change control, deviations and artworks / shade cards of printed packing materials are in place.

Responsible for product recall, if required due to market complaints or stability failure.

Responsible for training, development and evaluation of staff.

To conduct and ensure required initial and continuous training of departmental personnel, adapted accordingly to need and maintain record there of.

To ensure appropriate technology transfer are done at site. and wherever required appropriate action taken to improve quality of the product as per trend data.

Responsible for finished product batches are released as per approved regulatory filling / marketing authorization.

To ensure that approve validation protocols, Validation study reports and qualification protocols are in place and appropriate validation / revalidation, qualification / requalification are done as per approved protocol for process, cleaning, equipment, utility, facility.

To ensure compliance with regulatory requirement of applicable markets / country at site.

To assign the roles, responsibilities and authorities for persons in Quality Assurance site.

To ensure and lead investigation of market complaint, product failures, deviation and monitoring compliance to recommend corrective and preventive actions.

To participate in plant Quality review meeting and to assign respective CAPA and ensure the same at site.

To ensure the proper sampling during the process validation & cleaning validation.

To ensure the Media fill activity in aseptic filling.

Responsible for Preparation and review of departmental SOPs with implementation.

Review of Qualification documents, Site master file, VMP, Quality manual, Calibration manual, Process validation protocols, stability protocols, Annual products review and AHU Qualification.

Reviewing of Manufacturing, Packing BPRs, Logbooks, Formats and records.

Conducting the Risk assessment for equipment's & process.

Knowledge of cGMP & SAP,LIMS,ERP

Ensure proper execution of all IPQA related documents & Handling of finished goods and B.S.R.release.

Provide training of Good Documentation Practice (GDP), Data integrity &Document Data Contol.

FDA Approval:

For Microbiological analysis such as Sterility, BET, Assay, MLT & other related testing from the Govt. of Daman & Diu. (U.T).

Regulatory Exposure:

Following Regulatory Audits has been successfully faced

USFDA, TGA, UK MHRA, MCC, ANVISA, WHO-GENEVA,KENYA Customer Audits from ABBOT HEALTH CARE, JBPHARMA, ZEVENTIC, DR.REDDY,MERCK,SWISS PHARMA,

Previous work experience:

Company Name: AKORN PHARMA in PAONTA SAHIB (H.P) (US MNC)

Period : From Oct 2014 to May 2016

Designation : Manager –QA

Company Name: VAPICARE PHARMA in VAPI (GUJARAT)

Period : From Aug 2013 to Sep 2014

Designation : Manager –QA

Company Name: MANKIND PHARMA in Ponta Sahib (HIMACHLPRADESH)

Period : From Nov 2011 to Aug 2013

Designation : Deputy Manager –QA

Company Name: USV Limited in DAMAN,

Period : From Dec 2010 to Nov 2011

Designation : Assit.Manager –QA

Company name : Alkem lab limited (DAMAN)

Period : From Aug 2004 to Dec 2010

Designation : Executive (QA+QC)

Company name : Khandelwal lab limited (DADRA)

Period : From Sep 2003 to Aug 2004

Designation : Officer (QA+QC)

Company name : Biochem pharma limited (DAMAN)

Period : From Aug 2000 to Sep 2003

Designation : Chemist (QA+QC)

Privious

@ To prepare and implement Quality Assurance Procedures (QAP).

@To review and approve SOPs of various functional sections.

@To review and approve RMS/PMS/SPS/FPS.

@To review and approve quality system documents like, Change control proposals, Deviations, Incident reports, OOS and CAPA/Failure Investigations reports.

@To investigate market complaints and its recordation.

@To resolve non-conformance issues and initiate remedial action plan.

@To conduct building maintenance audit of shop floor.

@To monitor shop floor activities in line with SOPs.

@To plan and organize annual training plan with Training coordinator on cGMP and technical aspects.

@To coordinate with Corporate-QA professionals for international regulatory inspection.

@To coordinate with Regulatory department for various documentation job.

@To allocate job responsibilities to the QA professionals.

@Implementation and Development of QA system .

@Handling and participate in Internal Audits and External Audits.

@Handling and releasing of Finished Products .

@Participation for the Product process improvement and for new products development .

@Handling and development of Art Works and its final Approvals.

@Handling of Annual Products Review of Products.

@Handling of Documentation and Validation Activities.

@ Monitoring and work allocation as per the skills of persons.

@ Review the work output and pending works.

@ Ensure the Calibration and maintenance of all plant instruments .

@ Vendor Development and vendor audit for starting materials and Packaging materials.

@ Risk Assesment Study as per ICH Q9.

@ Responsibilities for monitoring stability studies as per ICH guidelines.

@ Design the protocol of process validation & cleaning validation activities.

@ Review the Process Validation, Cleaning validation, Water Validation Activities, Area- qualifications, Microbiological& HVAC Validation etc…& ensure the Qualification and validation activities in the plant.

@ Prepared the documents as per WHO (cGMP), MHRA (UK), MCC (South Africa), USFDA, TGA (Australia), WHO (Geneva) and other regulatory requirements.

@ On job training to subordinates to develop the person’s skills and improve the productivity.

@ Handling /Investigation of market complaints With CAPA.

@ Training of new employees as per the training procedure.

@ Design, Prepare, reviews and controls all the documents.

@ Vendor Development and vendor audit for starting materials and Packaging materials.

@ Responsible for monitoring and maintaining the cGMP system in the plant.

@ DCGI Submission.

@ Experience in SAP, LIMS.

@Ensuring periodic validation and Re-Validation related to process and Equipments/Instruments whenever required.

@Was responsible for preparation and updating of Site Master File & VMP.

@Ensured periodic validation and Re-Validation related to process and Equipments/Instruments whenever required.

Familiar Professional Responsibilities:

Testing of Raw material and Finished Product for Microbiological Test.

Preparation and maintenance of cGMP related documents.

In process checks in sterile bulk and sterile formulation.

Regular online checking of batch production record as per existing SOP and validation protocol.

Sterility testing as per USP/EP and Australian guideline.

Endotoxin Testing.

Microbiological assay by Cup Plate method of Antibiotics, Vitamines & Anticancer drug.

Culture Handling and identification by BBL crystal kit.

Microbiological Limit Test.

Validation of microbiological equipment.

Water Analysis – Chemical and Microbiological.

Viable monitoring of sterile area by settle plate, Active air, Swab, personnel monitoring and self monitoring, & Non viable particle count.

IPQA and compilation document.

Was responsible for periodic Monitoring of control samples and their documentation.

Did In-process checking and sampling for Intermediate, Bulk Finished and Finished Product.

Did issuance and retrieval of documents including BMR, SOPs, and other controlled documents.

Review the BMR and BPR of the export and domestic product.

Working standard preparation and to maintain consumption record.

Handled instruments such as IR & Spectrophotometer.

PROFESONNEL PROFILE:

Name : Devendra Kumar .B.Singh

Father Name : Badrinarayan. K.Singh

Present address : Near the post office of Antalia,

Taluka-Gandevi, Dist-Navsari,

Via- Bilimora, Pin-396325(Gujarat)

M.NO- 074********,942-***-****

E-mail Id: *********@*****.***

Permanent address : Near the post office of Antalia,

Taluka-Gandevi, Dist-Navsari,

Via- Bilimora, Pin-396325(Gujarat)

M.NO-074********, 094********

Date of Birth : 21/06/1979

Religion : Hindu

Martial Status : Married

Language Known : English, Hindi, Gujarati

MONETARY PROFILE:

Expected Salary : Negotiable

Joining Period : One Month from date of resignation

I hereby declare that the details furnished above are true to the best of my knowledge.

Place: Yours faithfully

Date: (D.B. SINGH)

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