Site Quality Assurance Head - Active Pharmaceutical Ingredient

Looking for Site QA Head for a leading API company in Hyderabad.

Job Description :

- Review and Approval of Annual product quality review documents.

- Review and Approval of Site Master File, Validation master plan documents for facility and responsible to keep these documents updated.

- Review and Approval of Installation/Operational qualification protocols/reports for the manufacturing equipment and new facility in co-ordination with Projects/Production departments.

- Maintaining the records of Job descriptions, Specimen signatures.

- Review and approval of Quality control instruments qualification/calibration documents.

- Review and approval of analytical method validations, Vendor Qualification.

- Review and Approval of Reprocessing / Reworking Batch production records.

- Review and Approval of performance qualification and process validation protocols of the Intermediates/ APIs manufactured in the facility.

- Review and approval of Standard Operating Procedures.

- Review and approval of technology transfer documents.

- Review and approval engineering related qualification documents (i.e. validation activities of critical systems including water system and Air Handling system).

- Review and approval of process flow charts, formats, calibration schedules, maintenance schedules, shift schedules.

- Review and approval of cleaning validation protocols for the multi-products manufactured in the plant.

- Conducting internal quality audits in the plant, issue reports and follow up for closure of non- conformance.

- Handling of Change Control procedures.

- Handling of el SAP related issues w.r.t quality.

- CAPA management.

- Preparation of audits responses and follow up for the closure.

- Review and Approval quality department monthly reports.

- Handling of deviations /00S/00T/Incidents/Customer complaints/Market returned goods and Approval in the track wise.

- Finished Product batch release after batch manufacturing record review.

- Review and Approval of Trend Reports of DM water-both chemical and microbial analysis.

- Co-ordinating with QA team for all QA related functions.

- Conducting the GMP Training programs for all employees.

- Handling of Customer Questionnaires, Dispatches, and Customer Agreements & Quality related documents.

- Review and Approval of Stability Protocols and Stability Data.

- Supporting to Regulatory Affairs and Business Development.

- Responsible for approving the induction certificates, Annual Training Curriculum,

- Training Group creation logbook, Annual training calendar training coordinators, Qualified trainer list, Job descriptions and identification and tracking of unscheduled trainings.

- Responsible for release of finished product for sale or to market.

- Responsible for Approving Standard Operating Procedure and Batch production records, Training modules and validation protocols.

Candidate profile :

Should be MSc Chemical or MSc/PG

Essential Experience: 15+ Years work experience

- Experience with QA measuring and testing equipment

- 5 to 8 years experience as QA Site Head

- Knowledge of safety requirements and legal standards

- Working knowledge of quality system requirements

- Experience with MS Word, Excel, Project Management and Analytics software