13 Aug
|
Umendra Life Sciences
|
Bavla
13 Aug
Umendra Life Sciences
Bavla
Role & responsibilities
- Handle day-to-day AQA/IPQA activities in manufacturing and packing areas.
- Perform line clearance and verify manufacturing/packing operations.
- Review BMR, BPR and other batch-related documents.
- Ensure adherence to GMP, SOP, GDP and quality procedures.
- Monitor manufacturing processes and identify quality/GMP deviations.
- Initiate and support investigations for deviations, incidents, OOS/OOT and complaints.
- Prepare, implement and monitor CAPA and Change Control.
- Support process validation, cleaning validation and qualification activities.
- Review QA-related SOPs, protocols, reports and records.
- Participate in internal, customer and regulatory audits.
- Ensure timely closure of audit observations and compliance actions.
- Conduct GMP awareness and documentation training for plant personnel.
- Coordinate with Production, QC, Warehouse, Engineering and other departments.
- Maintain proper documentation and ensure data integrity.
- Ensure continuous improvement of the Quality Management System (QMS).
Preferred candidate profile
- B.Pharm / M.Pharm / B.Sc / M.Sc with 48 years of relevant experience in Quality Assurance.
- Experience in Pharmaceutical, Cosmetic, Personal Care or regulated manufacturing industries preferred.
- Hands-on experience in AQA/IPQA, GMP compliance, line clearance and batch documentation review.
- Robust knowledge of cGMP, GDP and Quality Management Systems (QMS).
- Exposure to Deviation, CAPA, Change Control, OOS/OOT, Risk Assessment and investigation.
- Experience in process/cleaning validation and equipment qualification will be an added advantage.
- Good understanding of SOPs, BMR/BPR, audit compliance and data integrity.
- Strong documentation, analytical, communication and coordination skills.
- Ability to work effectively with Production, QC, Warehouse and Engineering teams.
- Candidates who can independently handle shop-floor QA activities and compliance requirements will be preferred.
📌 Senior Executive (Bavla)
🏢 Umendra Life Sciences
📍 Bavla