Expert Contractor Quality Assurance (m/w/d)
Key Responsibilities and Major Duties:
- direct supervision of the business and ensures, in particular, that medicinal products are handled appropriately
- ensuring that the quality of the medicinal products manufactured complies with the valid specifications and they are manufactured in accordance with the rules of Good Manufacturing Practice (GMP)
- issuing directives in its field of activity
- decision on the release or non-release of a batch independently of the management.
- Ensures the implementation and maintenance of quality management system, for the distribution activities with product in the Market.
- Escalates quality issues and decisions, which impact the business to Responsible Person.
- Supports compliance of market Third Party Distribution partners to Quality requirements related to distribution and transportation.
- Embraces continuous improvement activities for more effective Quality systems across the organization.
- This job description specifies function, duties, and responsibilities of the Dept. FvP within the Swiss affiliate
- Setup and maintain the Quality Management System
- Ensures that adequate processes are in place to ensure inspection readiness
- Ensures a close co-operation with the European Quality Organization; represents the Swiss affiliate in the corresponding European meetings and work streams.
This responsibility includes, but is not restricted to:
- direct technical supervision of all operations
- to ensure that medicinal products are handled appropriately and in accordance with any applicable Swiss law and regulation, as well as corporate policies and procedures
- to ensure that medicinal products are distributed in accordance with the rules of good distribution practice (GDP), this includes:
- ensuring that a quality management system is implemented and maintained;
- focusing on the management of authorized activities and the accuracy and quality of records;
- ensuring that initial and continuous training programs are implemented and maintained;
- coordinating and promptly performing any recall operations for medicinal products;
- ensuring that relevant customer complaints are dealt with effectively;
- ensuring that suppliers and customers are approved;
- approving any subcontracted activities which may impact on GDP;
- ensuring that self-inspections are performed at appropriate regular intervals following a pre-arranged program and necessary corrective measures are put in place;
- keeping appropriate records of any delegated duties;
- deciding on the final disposition of returned, rejected, recalled or falsified products;
- approving any returns to saleable stock;
- ensuring that any additional requirements imposed on certain products by national law are adhered to give binding instructions to personnel and contractors within his sphere of activity.
- to acquire and maintain the necessary Ievel of expertise and experience through continuous education
- to ensure that any medicinal products released onto the Swiss market meet the approved specifications and are produced in accordance with Good Manufacturing Practice (GMP).
- to decide, independently of the management of or its mother company, whether or not a batch can be released to the Swiss market; or if a batch already released has to be recalled .
- assess the periodic quality reviews for all products approved for the Swiss market