Objective of the role: Maya Zist Farayand is belongs to Padideh Shimi Paydar. Maya Zist Farayand is seeking a Quality Assurance Manager for pharmaceutical factory (API and finish dosage). The individual in this role will be responsible for providing Quality leadership & support and lead Quality improvement initiatives related to aseptic fermentation and solid oral dosage manufacturing activities. The individual will work with internal functions to ensure robust processes and systems are implemented in support of Maya Zist programs. This individual will develop and execute based upon implemented quality systems / standards. The successful candidate must have experience in a biotech or pharmaceutical development environment and knowledge of cGMP quality systems..
List of responsibilities: Manage a quality assurance team to support oversight on operational duties as described below:
• Write, review and approve GMP documentation for MOH (Ministry of Health) such as SMF (Site Master File), Quality Manual, CTD (Common Technical Document), Material/Personnel/Waste/Sample flow drawings, etc.
• Write, review and approve GMP documentation (SOPs, protocols, technical reports, technology transfer protocols, specifications, summary reports to support GMP production, change controls, etc.).
• Review batch records, associated testing records, and other documentation to ensure that all steps have been executed correctly, verified where applicable, and that all limits and specifications have been met.
• Develop and maintain Quality Agreements with contract manufacturers, suppliers, and laboratories.
• Review and approve Validation Protocols and reports to ensure compliance.
• Support Annual Product Review report generation and approval.
• Review protocols, analytical results, and documents associated with investigations, OOS results, etc., and corrective/preventive action plans.
• Support disposition of API and finished drug product batches.
• Review stability protocols and reports.
• Collaborate with Manufacturing and lead investigation teams to resolve equipment and process related deviations.
• Conduct internal audits, track progress, and trend results.
• Participate in relevant supplier audits as needed.
• Generate targeted metrics for Management Review.
• Review relevant sections of regulatory filings.
• Provide guidance on GMP manufacturing from Phase I to Commercial..
Length of Probation Period: 2 Month.
Working hours: 7:30 to 16:45 Saturday to Wednesday.
• BS or Master’s level degree with at least 5 years of experience in the pharmaceutical/biotech industry.
• Working knowledge of relevant FDA, EU, ICH, PICs guidelines and regulations.
• Experience working with CMOs, vendors, and relationship management preferred.
• Experience working with aseptic fermentation and oral dosage finish products.
• Excellent judgment and ability to communicate complex issues in an understandable way.
• Ability to manage multiple projects in a fast-paced environment, project management experience a plus.
• Ability to effectively collaborate in a dynamic, cross-functional matrix environment.