senior quality engineer

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.
Candidates preferred from glass industries
Qualification – Diploma or BE
Experience – 8 to 10 Years
Reporting – Department Head

experience

10