Manager - Quality Assurance (Biologicals)

Zifam Pinnacle, the parent company of Delta Biopharma, has vacancy for a Manager - Quality Assurance (Biologicals) for its upcoming Biologicals manufacturing plant in Yangon, Myanmar.

The plant will be designed specifically for Fill & Finish of Biologicals and will be designed as per EU standards.

The Manager - QA will be responsible for all QA, IPQA, validation, and the entire QMS, in the Biologicals (injectable) manufacturing.

It is expected that the candidate will have UG/PG in life science (such as B Pharm/M Pharm) with at least 12 to 20 years of experience in Quality Assurance of injectables manufacturing, and a thorough knowledge of EU Annex 1, US FDA and similar regulatory requirements. The candidate must have experience in handling Regulatory Audits and managing Audit response.

Responsibilities include, but are not limited to:

Management of Quality Assurance

• Developing and reviewing QA documentation including specifications, SOPs, maintenance, calibration, validation (e.g. Process validation, Cleaning validation etc.) and Product Quality Review (PQR for compliance).
• Developing and implementing QA system for ensuring compliance with regulatory documents and cGMP standards.
• Manage customer complaints.
• Maintenance of the out-of-specification, deviation and change control programs.
• Manage stability monitoring system.
• Manage internal and external audits, regulatory inspections and follow-up actions.
• Review and approve batch production records for intermediates and final biological products.
• Preparation, Execution and Review of Aseptic Process Simulation Protocols and Reports.
• Ensure deviations are adequately investigated and resolved prior t o batch release.
• Conduct investigation o f deviations, OOS/OOT results and quality incidents.
• Ensure timely implementation and effectiveness checks o f CAPA.
• Monitor KPls (deviations, CAPA effectiveness, audit findings, EM trends, etc.).
• Approve supplier qualification, audits and periodic monitoring.
• Ensure raw materials, components and critical suppliers comply with biologicals GMP requirements.
• Oversee validation master plan (VMP).
• Review and approve validation/qualification protocols and reports for equipment, utilities and computerized systems validation (CSV).
• Implement and maintain ICH Q9-compliant quality risk management processes.
• Conduct risk assessments related to product, process and tacility.
• Ensure facility is prepared for regulatory inspections (USFDA, E U GMP, WHO, national authorities etc.).
• Maintain awareness of evolving GMP regulations specific to biological products.
• Lead quality improvement projects.

Management of Training

• Schedule and implement the Internal Faculty Group Training Plan.
• Manage the GMP Induction and Job-Related Skill Internal Training for individual employees.
• Evaluate the Training Effectiveness.
• Co-ordinate the External Training and appraisals.

This is a full time role and requires the candidate to relocate to Yangon, Myanmar. If you believe that you are the right candidate for the role, please apply and send your resume.