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.
