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Role: Quality Engineer / Sr Engineer (IPQC – In Process Quality Control). Department: Quality. Employment Type: Full Time, Permanent. Role Category: Production & Manufacturing. Location – Vemula, Mahbubnagar. Shift – Ready to work in rotational shifts.
Requirements:
Aware of processes needed for the QMS, GMP are identified, established, implemented and maintained as per ISO 9001:2015, ISO 15378:2017
Accountable for control and issue of documents related to QMS, GMP management systems as per Documentation system and control of documents
Accountable for control of records
Coordinate DMF related activities and amendment filings as per requirement
Ensuring the promotion of awareness of customer requirements throughout the organization
Acting as lead auditor and Conducting Internal Audits of QMS, GMP
Organizing Management Review Meetings of QMS, GMP
Conducting training and refresher training on QMS, GMP
Review the management of changes in QMS, GMP as per change control procedure
To take plant round and monitor production activities at shop floor
To prepare appropriate Quality related documents like SOP, BMR, BCR, BPR etc
To review BMRs, BCRs, and analysis records before release of API
Facilitating the implementation of preventive and corrective actions
Coordinate for compliance with applicable legal and other requirements
Coordinate emergency response efforts
Preparation of validation protocols for equipment, process, clean rooms and participate in validation activities of equipment and procedures