Global quality & Compliance Lead

Position Summary :

 Manage overall batch certification review of QC lab records, certificates of analysis/compliance and all related supporting documentation (i.e. documentation review, SOP compliance, laboratory application data reviews, instrument preventive maintenance/calibration/qualification/validation as per good manufacturing practices/good documentation requirements and ALCOA++ principles). This role will be an individual contributor with expert in manufacturing investigations from FDA approved facilities that make sterile and OSD products. The incumbent will assure individual compliance with all concerned regulatory requirements, GxP’s and applicable department programs, including training, documentation, standard operating procedures, and Sun Pharma policies and procedures.

Key Responsibilities :

Lead the review of all QC records related to Batch certification program. QA SME for manufacturing & packaging Investigations (Sterile & OSD) Batch Certification activities at Dadra and possibly other sites in India.

 Experience in manufacturing contract manufacturing organizations, inculding Batch records, investigations and product quality compliants.

 Experience in FDA and Health Canada inspections Review Deviations, CAPAs, OOS/OOT investigations.

 Ensure that all activities are compliant with Standard Operating Procedure, STP and GP etc.

 Review initiated CAPA records related to QC investigations for completeness and adequacy.

Review and approval of qualification, analytical method transfer, validation protocol and reports for accuracy, completeness and traceability as well as adherence to the Protocol/procedures.

Training of QC and QA teams. Work in partnership with Quality Control and Quality Assurance. Follow the EHS policy, laboratory procedures and maintain the compliance to cGMP requirements. Travel Estimate