Team Member - QA QMS

Roles & Responsibilities:

• • Handling of QMS activities like change control, Deviations, CAPA, Market complaints Recalls and Returned goods as per the predefined procedure product as per procedure.
• To involve in Regulatory filings and query response.
• To access Cross site applicable CAPA at site.
• To ensure compliance of SOP for closure of Deviations within timelines.
• To carryout Deviation/Market Complaint/CAPA trends as per procedure.
• To involve in the Management of Risk Assessments and Risk Summary.
• Review of all logbooks used in Production, Packing, Quality Control, Engineering & Warehouse area.
• Ensure the compliance in the manufacturing facility or area with respect to the cleanliness, and labelling as per the cGMP.
• Responsible to carry out the investigations and timely closure of the same within the time line.
• To involve in QRM and Tracking actions periodically.
• To Carry out any other job assigned by the Head of the Department, Quality Assurance.
• To carry out the Document life cycle management as per the approved procedure and applicable software’s.
• Annual Product quality review.
• To participate in handling of internal and external audits (Customers/Regulatory agencies). Coordinate with plant QA for preparation of response and appropriate CAPA.
• Responsible to evaluate the gaps, with respective to current regulatory expectation and observations in pharmaceutical industry.
• Initiation and handling of Quality Notification of Deviations, CAPA, OOS & OOT/FAR/QDN/Recall and Change controls through applicable software’s.
• Review of change controls through as per applicable software.
• Responsible for participation in the investigations i.e. OOS, OOT, Deviations and ensure its closures within the timelines.
• Periodic review of the area, equipment and the instruments are in validated and calibrated state.
• Review of SOP’s, Protocols, Reports, Qualification documents, Deviations/OOS/OOT/Market Complaints/Recalls/FAR/QDN.
• Responsible for co-ordination with RA for Data Submission.
• Responsible for maintaining the licenses and Quality Technical Agreements and communication to SCM and RA personnel for license updation.

Function: Other
Experience Level: Mid-Senior Level