Senior Executive - Quality Assurance
Summary
Senior Executive QA responsible for quality oversight and compliance of QC and manufacturing activities, including batch release, electronic data/audit trail review, QMS management, and cleaning validation at a pharma CDMO.
Be the First to Apply
Division
Piramal Pharma SolutionsPiramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.
This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.
Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.
For more details, please visit :
Job Title
Senior Executive - Quality AssuranceJob Description
As A Senior Executive – Quality Assurance is responsible for ensuring quality oversight and compliance of QC and manufacturing activities through comprehensive review of analytical data, batch records, and QMS elements. The role involves batch release activities, review of QC data, including electronic and documented/manual records, audit trails and ensuring adherence to cGMP, data integrity, and regulatory requirements. The incumbent will also support cleaning validation, line clearance, dispatch activities, and preparation and review of Annual Product Reviews (APR) to ensure consistent product quality and regulatory compliance.- Review and evaluation of QC analytical data, including thorough electronic data and audit trail review to ensure data integrity.
- Review of analytical specifications, STPs/analytical procedures, protocols, and laboratory-related SOPs.
- Review of QC laboratory qualification/calibration status of analytical instruments.
- Batch Release Management.
- Hands on analytical experience.
- Review of batch manufacturing and packaging records, including audit trail verification.
- Preparation and Review of APR.
- Oversight and review of QC laboratory activities to ensure adherence to SOPs and quality standards.
- Initiation, investigation, and review of QMS elements such as Deviations, Change Controls, OOS, OOT, and CAPA.
- Review and execution of cleaning validation activities in accordance with regulatory guidelines.
- Support during regulatory inspections and customer audits.