Job Description

Department Details

Role Summary

Handling of QMS elements & handle the investigations.

Key Responsibilities

Handling of QMS elements:
• Review and closure of QMS Document.
• Provision of site acceptance/review for QMS as per need basis.
• Issuance, reconciliation, and archival activities of GXP documents.
• Preparation, review and approval of quality documents (SOPs, planner, schedule etc.)
• Perform trend analysis of QMS Parameters.
• Review of QMS for routine batch release or rejection.
• Preparation, Review and approval of Annual Product Quality Reports annexures for QMS parameters.
• Authorised to Conduct trainings as per Training management SOP requirements.
• Co-ordination with corporate functions to implement various systems and procedures.
• Preparation, Review and Approval of Risk Assessment protocol, FMEA and reports.
• Support for Management Review meeting for QMS.
• Conducting monthly quality review meetings.
• Handling of reprocess / reworking of batches.
• Adherence to the covid protocol guidelines until normalcy is restored. Keeping abreast about the business continuity plan
• Handling of digitalized software’s.
• Handling of errata
• Ensure timely completion of training assigned in SF. Review and accept the JD formally presented by the reporting manager.
• Ensure timely and accurate documentation is maintained on principles of GDP and DI.
• Addressing the data integrity/GDP non-conformance and escalating to senior management.
• Providing insights for site specific SOPs and corporate in terms of procedural improvement and guideline requirements.
• Complying with all applicable quality/EHS policies/procedural adherence.
• Adherence to company/Quality/EHS policies and procedures
• Co-ordination for review of corporate procedure CFT site 2 specific procedures and providing insights.
• Keeping abreast of basic Engineering procedures and general production procedures for handling the QMS elements. Conduction of GMP rounds/self inspections
• Ensure that training is completed with successful certification on course before taking up any additional responsibility delegated by reporting manager.
• Review of process validation and cleaning validation; study protocol and report/ area and equipment qualification records/quality documents on need basis.
• Review of the startup and shut down of the facility.
• Escalate all nonconformances requiring escalation with relevant information to senior leadership.
• Coordinating with cross function team members for achieving quality requirements.
• To ensure that processes needed for the QMS are established, implemented and maintained in the site.
• Compiling and Reporting to management on the performance of the quality system and any need for improvement as per Governance SOP for QMS..
• Ensuring the promotion of awareness of regulatory and customer requirements in the organization in the site.
• Verification and approval of specimen signatures.
• Providing compliance w.r.t. assigned task in Compliance risk management.

Educational Qualifications

Required Education Qualification: M.Sc
Required Experience: 7 – 10 years