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.

Designee Responsibilities:

• 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