Quality Control Raw Material
Resume:
CURRICULUM VITAE
TARVEEN
Mobile: +91-797*******
Email ID: *********@*****.***; *******************@*****.*** OBJECTIVE:
To apply for a challenging position in the field of Quality control of Pharma industry that offers an opportunity to work in an organization, where my expertise and experiences used to best way and that would provide for organization's growth and to develop my carrier. SUMMARY:
Skilled Pharmaceutical professional with 17 + years of experience in reputed pharmaceuticals industries. Knowledge of quality control activities with strong analytical abilities and strategic planning skill. Excellent interpersonal skills, proficient in computer skills and ability to meet deadlines. AUDIT EXPOSURE:
USFDA, ANVISA, FDA UGANDA, TFDA TANZANIA, WHO GMP, PICs, KFDA Kenya, Rwanda FDA, Ukraine, MFDA, Peru (DIGEMID), Pre audit of EUGMP etc. PRODUCT EXPOSURE:
Injection (Dry, Liquid, Prefilled syringes & Lyophilized) and Tablet, Capsule (Hard gelatin and soft gelatin), Liquid oral, Ointment & Liquid inhaler.
PROFICIENCY:
Raw Material, Packing Material, In-process and finished product analysis management.
Stability study management,
Instrument calibration and qualification,
Incident, OOS, OOT and OOC,
Method transfer and method validation,
Standard Operation Procedure,
Specification and testing procedures,
Change control,
CAPA,
URS,
Risk assessment,
Audit and compliance,
Standard management,
Column management,
Training management
Excel Sheet validation,
Computer system validation,
SAP,
ERP,
New project execution.
Biological Assay (Enoxaparin Sodium, Heparin Sodium & Hyaluronidase) FDA Approval in instrumentation and chemical.
EMPLOYMENT HISTORY:
Organization: Samarth Life Science Pvt. Ltd. (Unit-II), Baddi Designation: Assistant manager-QC Period: April 2021 to till date Role (Section): Quality control Reporting to: QC Head & Quality Head Team strength: 30
Responsibilities:
Responsible for proper functioning of GLP section,
Ensure compliance at the site (Quality control aspects) as per regulatory requirement,
Raw Material, Packing Material, In-process and finished product analysis management,
Timely investigation and closing of incidents, OOC, OOT & OOS,
Handling of change control and CAPA,
To ensure GLP, GDP and online documentation in Quality Control Department,
To ensure submission of error free documents to IRA Department,
Review of standard operating procedures,
On the job training,
Standard management, chemical management and column management,
Self-inspection in Quality Control Department,
Internal and external calibration of laboratory instruments,
AMC/CMC contract and preventive maintenance of laboratory instruments,
URS preparation,
Environment study of volumetric solution and working standard.
Cleaning validation of glassware.
Capex preparation,
Calibration and Qualification of laboratory instruments,
Active participation in regulatory & internal audits and their compliance,
New Quality Control Laboratory set up,
Assistance to QC Head in various activities,
Organization: Samarth Life Science Pvt. Ltd. (Unit-II), Baddi Designation: Sr. Executive-QC Period: April 2019 to March 2021 Role (Section): GLP Quality control Reporting to: QC Head Team strength: 5
Responsibilities:
Responsible for proper functioning of Audit & GLP section.
Timely investigation and closing of incidents, OOC, OOT & OOS.
Handling of change control and CAPA.
To ensure submission of error free documents to IRA Department.
Review of standard operating procedures and standard testing procedures.
On the job training to analysts and analyst qualification.
Standard management, chemical management and column management.
Internal and external calibration of laboratory instruments.
AMC/CMC contract and preventive maintenance of laboratory instruments. Organization: Samarth Life Science Pvt. Ltd. (Unit-II), Baddi Designation: Executive-QC Period: April 2016 to March 2019 Role (Section): Raw Material, Finish & Stability section Reporting to: QC Head Team strength: 5
Responsibilities:
Raw Material, Packing Material, In-process and finished product analysis management.
Stability study management.
Ensure analysis & timely release of In-process & Finished products.
Ensure charging, withdrawal and analysis of stability samples within window period.
Review of intended and executed stability protocols and trend of stability samples.
Review of stability protocols and trend of stability, Raw Material, Packing Material, In- process and finished product.
Review of method transfer and method verification. Organization: Nootan Pharmaceuticals
Designation: Executive -QC Period: Nov. 2012 to April 2016 Role (Section): RAW Material Section Reporting to: QC Manager Team strength: 4
Raw Material, Packing Material, In-process and finished product analysis management.
In-process and finished product analysis management. Organization: Cadila Healthcare Ltd. Baddi
Designation: Officer-QC Period: May 2010 to Nov. 2012 Role (Section): FG & Stability Reporting to: QC Manager & Section Head Responsibilities:
Analysis of In-process, Semi-Finish, Finish products and validation samples.
Method transfer and method validation.
Charging, withdrawal, analysis and destruction of stability samples.
Monitoring of stability chambers.
Updation of stability reports
Organization: Adley Formulations
Designation: Officer-QC Period: Aug 2006 to May. 2010 Role (Section): Analysis Finish product Reporting to: Section Head Responsibilities:
Analysis of In-process, Semi-Finish, Finish products and validation samples. INSTRUMENT HANDLED
HPLC (Waters with Empower, Agilent with Chromeleon, & Shimadzu with Lab solution)
GC-HS (Agilent with Chromeleon and Shimadzu with Lab Solution software)
UV Spectrophotometer (Shimadzu)
FTIR Spectrophotometer (Shimadzu)
Particle Size Analyzer (PMS)
Auto Titrator (Labindia & Metrohm)
Dissolution Apparatus (Electrolab & Lab India)
Polarimeter (Anton Paar & Jasco)
AAS (Shimadzu)
RF-6000 (Shimadzu)
Reflective index (Anton Paar & Jasco)
Vacuum Rotary Evaporator (Tanco)
Elisa Reader
COMPUTER APPLICATION:
MS-Office (MS-Word, Excel, Power point etc.)
ADEMIC QUALIFICATION
Master of Science (M.Sc.- Chemistry)
Bachelor of Science (B.Sc.-PCM)
Intermediate
High School
PERSONAL DETAILS:
Father’s Name : Sh. Satya Pal Singh
Date of Birth : 10th September, 1980
Marital status : Married
Languages Known : English and Hindi
DECLARATION:
I hereby declare that all above information is true and authenticated to best of my knowledge.
(Tarveen)
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