Quality Assurance Manager

JOBDESCRIPTION

To ensure appropriate quality management system in thecompany, to meet all regulatories and customers requirements.

• Ensure and establish an appropriate quality management system to meet customers and authorities requirements following appropriate guidelines.
• Ensure the Quality Culture Program is carried out.
• Ensure department target and schedule, and company target is met.
• Ensure preparation of GMP and product-related documentation and review.
• Ensure Change Control, Events (Deviations and Incidents) DIR, OOS, OOT, and complaint investigation and resolution and review.
• Ensure validation activities and quality risk assessment execution as per requirement.
• Ensure execution of qualification activities and review.
• Approval of Product release or rejection (Product Status Note).
• Ensure GMP training executions as per requirement.
• Approval of supplier and external contractor.
• Involved in internal and supplier audits.
• Ensure execution of cleaning studies/validation activities.
• Assist in handling all customers requirements for questionnaires, declarations, statements, etc.
• Ensure the sales quality requirement of customers is met.
• Assist in correspondence, notification, and communication with customers via e-mail and/or conference calls.
• Ensure proper and smooth Technical transfer of new product.
• Ensure smooth customer and regulatory audits/inspection.
• Ensure mock recall or recall execution.
• Ensure timely implementation of CAPAs and their effectiveness monitoring.
• Involve in Q&CM (HQ-QA) documents review and discussion for improvement of QMS in the company.
• Any other QA department job assigned by the Head of the Quality Division.

REQUIREMENTS

. Universitydegree in chemical related field.

. Minimum5 years of QA related working experience.

. GMPexperience in pharmaceutical field is preferred.