Responsible for Overall Quality Management System.
Responsible for Approval of general documents (but not limited to) Site Master File, Validation Master Plan, Validation/Qualification Protocols/ Report & yearly calibration Calendars. PM Planners, BMR/ BPR, SOPs, APQR, IPQR, Specifications, Standard testing procedures, general testing procedures etc.
Responsible for review and approval of market complaint, change control through EQMS, OOS, OOT, product recall, mock recall and coordination of same with third party/ regularly for intimation/ notification/approval.
To form investigation team and monitor effective implementation of CAPA associated with incidents, OOS, complaints, deviation, OOT recalls or any other quality element.
Responsible for compliance with technical or regulatory requirements related to the quality of finished products and the approval of the release of finished product distribution and sale.
Responsible for inspection, investigation and taking of samples in order to monitor factors that may affect product quality.
To ensure compliance of data integrity either manual data or electronic record.
Implementing and monitoring all Quality Assurance systems to ensure compliance with CGMP/regulatory guidelines, develop progressive Quality Culture across the organization.
Developing and implementing the Quality departments strategy, to ensure it meets the business requirements and customer deliverables, as well as enhancing the departmental performance.
Implementing and maintaining a Quality Risk Management system to ensure that risks are adequately controlled and deliver a quality product as per CGMP.
Reviewing and approving Technical and Quality Agreements.
Work across all disciplines (e.g. manufacturing, packing, warehouse, engineering, QC, QA, RA, HR, R&D) to ensure the all-time readiness of plant for various GMP compliance audits.
Ensuring that all activities are performed in accordance with CGMP, company SOPs and Health and Safety policies.
Audit, Approval and monitoring of contract manufacturers, Supplier and outside Laboratories as per GMP requirement.
Responsible to ensure that process validation, cleaning validation, equipment validation, Preventive maintenance, calibration etc. activities are being carried as per schedule.
Responsible to ensure self-inspection/internal audit is being performed as per schedule and its compliance.
Ensure that training & development program implemented as per respective SOPs.
Responsible for external audit and its compliance.
Responsible to ensure to update all legal/ technical changes with respect to new pharmacopoeia/addendum/guidelines.
Responsible for ensure stability studies of products are being performed as per schedule.
Overall monitoring of new product introduction through technology transfer documents.
Responsible to follow EHS Policies.
Responsible to ensure implementation of quality policy of the organization.
