Key Roles and Responsibility:-
-Implementation and review of Quality Management System at the site through regular tracking and monitoring.
-Facilitates updating of all Quality systems/ process/documents i.e. Standard Operating Procedures and work instruction as per the QMS requirements to have consistent Quality of the products produced.
-Issuance and Retrieval of the documents and SOPs.
-Ensure issue and review of BMR/BPR for effective process/ product control.
-Prepare Site Master File as per the current practices for submission to regulatory authorities.
-Ensure document and records are stored safely.
-Facilitates validation of manufacturing process and equipment’s. Ensures that appropriate validations are carried out as defined in the approved Site validation master plan, completeness of all validations, protocols and final report.
-To Coordinate and carry out the Internal Quality audit and support the site to meet the QMS requirements
-Ensures effective implementation of Change Control programs, Deviation, Non- Conformances and review of OOS
-Evaluates and ensures implementation of corrective action plan drawn due to deviation and out of specifications results, customer complaints which may have an impact on product Quality
-Co-ordinates and conducts training program’s on GMP, Quality Management Systems, SOP’s for employees to bring Quality awareness and concept of Quality ownership.
-Handling of Customer complaints to ensure effective resolution of the problem
-To support the site team in customer audit readiness, preparation of CAPA and monitoring of the compliance of the actions on regular basis. Ensure that the Annual Quality Reviews/ MRM are carried out, MOM is prepared and circulated for effective implementation of action point
-Ensure that the Annual Quality Reviews/ MRM are carried out, MOM is prepared and circulated for effective implementation of action point
-Ensure finished product release as per laid down procedure. All Quality related issues are escalated to the management
Qualification: B.Sc. in Chemistry
Experience: 3-6 Years