Senior officer ipqa medical device

2 weeks ago


Ahmedabad, India Biotech Healthcare Full time

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 c GMP, regulatory guidelines and quality standards during various stages of manufacturing. Desired Candidate Profile: 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: c GMP, 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 (c GMP) 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 c GMP 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, c GMP, 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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