Duties and Responsibility
· Quality Management Systems (QMS).
· Experience of Customer Audits, Internal Audits across Sites.
· Validation & Change control of products.
· Handle Market Complaints and CAPA, SOPs approvals.
· BMR, Vendor Approvals.
· Experience Regulatory Affairs, ISO Certification & CE marking Certification.
· Readiness for regulatory audits to sites
· To ensure all time readiness of sites (currently but limiting to Dehradun, Selaqui, R and D Formulation and R and D- Dosages) for various regulatory audits
· To ensure establishment and maintenance of current Good manufacturing practices at sites through periodic audits and ensure implementation of effective CAPA
· Qualification of Vendor and Contract manufacturer of Indian Business
· To Support sites for vendor audits and to ensure the qualification of vendor
· To ensure compliance at Indian generics contract manufacturing sites (Dosages form)
· Evaluation of critical quality event
· Involve in the investigation of critical quality events of manufacturing sites to bring it to logical end
· Review of OOS of sites and provide logical comments for implementation
· Tracking compliance for the management notification
· Monitoring Quality dashboard of sites
· Monitory regulatory committed CAPA and its compliance
· Regulatory compliance/ Automation and harmonisation
· Impart training on various quality system at sites
· Harmonization of Quality management system across the sites
· Regularly update to sites for the GMP/GLP updates, GMP trends, pink sheets
· Responsible for implementation of automation at site as coordinator
· Approval and rejections of change control and deviations related to pilot bio batches manufactured in GMP area at R and D II
· Review of Technology transfer documents as per QbD to ensure adequacy and accuracy
· Harmonization of procedures and practices: Draft / review / update Policies , Procedures related to Microbiology, CAPA, change control, deviation & QMS, training; Harmonize the Procedures related to Microbiology, CAPA, change control, deviation & QMS, training; across all units Improving breadth and depth of Knowledge: Identify and lead in above
· Subject Matter Experts. Act as a CQA Trainer for Microbiology related Training programs. Investigations and CAPA
· Act as CAPA coordinator for the CAPA
· Act as Cross Functional Reviewer (CQA) related changes, Non-conformances OOS etc, wherever applicable.
· Act as Internal Auditor quality Assurance area, wherever required. Proactively assess risk, plan and execute audit deliverables. Work with sites to ensure their sterility assurance systems are properly prepared for external and internal compliance inspections.
· Escalate concerns & quality Assurance related issues to Senior Management.
Brief Job Description:
- To Lead the CQA team and Ensure the harmonization of Procedures and practices related to QA, QC, R&D, & Production.
- Assuring compliance with GLP, GCP and cGMP requirements typically GxP solution, implementation of quality systems, inspections and checks during the design and development of pharmaceutical products.
- Assuring compliance with International regulatory operations including compilation of dossiers for drug application and submissions.
- To ensure Employee training on GLP, cGMP & GCP.
- Act as a CAPA coordinator and internal Auditor.
- To conduct regular audit of Raw and Packaging Materials & Third party.
- To help regulatory affairs team.
- Proactively assess risk, plan and execute audit deliverables. Work with sites to ensure their systems are properly prepared for external and internal compliance inspections.