Principal Account Lead at Randstad India
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Site Quality Assurance Head - Active Pharmaceutical Ingredient (15-20 yrs)
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