Biotech Healthcare | Senior Officer IPQA Medical Device | ahmedabad
2 weeks ago
Role Objective:
A key objective of this profile is to ensure that all manufacturing processes adhere to standard operating procedures (SOPs) and regulatory standards. Role involves monitoring in-process quality assurance (IPQA) activities to ensure compliance with cGMP, regulatory guidelines and quality standards during various stages of manufacturing.
Desired CandidateProfile:
Education: Bachelor’s degree in Pharmacy, Master’s degree in Biotechnology, Life Sciences or a related field.
Experience: 1-3 years of experience in Quality Assurance within a regulated manufacturing environment, preferably in medical devices or pharmaceuticals.
Certifications: cGMP, ISO 13485 or equivalent QMS-related certifications are advantageous.
Skills: Strong analytical skills, attention to detail, and proficiency in line clearance activities.
Role & Responsibilities:
- Oversee IPQA activities to ensure adherence to Standard Operating Procedures (SOPs) and regulatory standards.
- Supervise the implementation of current Good Manufacturing Practices (cGMP) on the shop floor.
- Perform in-process checks based on predefined process parameters outlined in the Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR).
- Ensure the completeness and accuracy of cGMP documentation and verify the entries in the online BMR/BPR.
- Monitor and evaluate the effectiveness of Corrective and Preventive Actions (CAPA).
- Participate in process validation and report any non-conformities or deviations observed during production.
- Verify preventive maintenance documentation and monitor environmental conditions in critical areas and cleanrooms.
- Conduct pre-dispatch quality checks in accordance with established procedures before the dispatch of finished goods.
- Assist in investigating non-conformances, market complaints or product failures and contribute to ensuring GMP compliance.
- Oversee the proper disposal of materials in accordance with approved protocols.
- Release all Order Booking Dispatches (OBD) in SAP.
Functional Skills Required:
- Proficient knowledge of QMS, cGMP, and regulatory standards such as ISO 13485.
- Strong understanding of quality assurance processes in manufacturing environments.
- Familiarity with documentation systems such as BMR, BPR, and CAPA.
- Experience in environmental monitoring within critical areas and clean rooms.
Behavioral Skills Required:
- Strong analytical and problem-solving skills.
- Excellent communication and teamwork abilities.
- High attention to detail with the ability to manage complex tasks under pressure.
- Proactive in identifying and resolving quality-related issues.
- Commitment to continuous improvement and operational excellence.
Team Size to be Handle:
- Individually Contributory Roll, reporting to Manager – IPQA & Validation.
Learn more at:
Biotech is an Equal Opportunity Organization promoting diversity while ensuring no discrimination on any ground including gender, race, religion, age, sexual orientation, disability, etc.
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