Trackwise
PREENA PRASHAR
Gurgaon
Summary
To pursue a challenging and responsible career in a reputed Pharmaceutical Organization where I can contribute my skills and abilities in a motivating environment.
Overview
7
7
years of professional experience
Work History
Executive
Getwell Pharma India Pvt. Ltd.
12.2022 - Current
- Preparation of Annual Product Quality Review (APQR) by coordinating with the cross-functional department.
- Handling of Audit Management and Audit Compliance.
- Preparation of Site Master File (SMF) and SOP’s related to Quality Assurance functions, documentation and Controlling.
- Handling of SOPs viz SOP’s effectiveness, controlling, archival and Issuance.
- Line Clearance and sample collection and management w.r.t Control sample and Stability samples.
- Handling of batch release by reviewing executed batch records and providing COA’s.
- Management, control, retrieval and issuance of the Specifications, Standard testing procedures and other documents required for references.
- Management of Documentation room during Audit and Inspections to ensure fast availability of the documents.
Senior Officer
Alkem Laboratories Ltd.
08.2017 - 01.2022
- Handling of Audit Management and Audit Compliance (in Trackwise).
- Handling of Change Control assessment and closing (QA evaluation summary and final closing) in Track wise.
- Handling of SOPs viz. SOP’s Preparation, review, effectiveness, controlling, archival and Issuance in caliber DMS.
- Document and Data Control viz. Issuance, retrieval and archival of formats in caliber DMS.
- Handling of supplier Complaints.
- Assignment of Room and Equipment/Instrument Identification Number and related records.
- Controlling and Reconciliation of the Master documents –SMF, VMP, Quality manual, Planners, Misc.
- Documents etc Management, control, retrieval and issuance of Key documents, Master documents and other documents required for reference.
- Back-up room management and controlling during Audits to ensure quick availability of the documents.
Education
B. Pharmacy -
Punjabi University, Patiala
XII - undefined
Shiwalik Public School, Ropar
Skills
Communicationundefined
Audit Exposure
REGULATORY AUDIT : USFDA, EU-GMP, TGA, SAPHRA, ANVISA, IFDA, WHO, CDSCO
CUSTOMER AUDIT : Ennogen, Wave Pharma, Cardinal Healthcare, Ascend Laboratories
Disclaimer
I do here by declare that the above and said information are true to the best of my knowledge.
Software
Nichelon
Caliber e-DMS
Timeline
Executive
Getwell Pharma India Pvt. Ltd.
12.2022 - Current
Senior Officer
Alkem Laboratories Ltd.
08.2017 - 01.2022
B. Pharmacy -
Punjabi University, Patiala
XII - undefined
Shiwalik Public School, Ropar
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