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Expert Contractor Quality Assurance (m/w/d) (EN)
[13515]
QA, FVP
Job title: Expert Contractor Quality Assurance (m/w/d) Industry: Biotech Skills: QA,FVP Start of project: 01.10.2023 Duration of the project : 9 months Project volume: 0 Hour(s) Location: 6312 Steinhausen, Schweiz Hours per week: Oct 2023 3 days/week; Nov 2023 – June 2024 4 days/week ( flexible) Location: Steinhausen, on site 50% of the time Language: DE and English fluent 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 ·The Deputy FvP is acting in absence of the FvP as "Responsible Person" (fachtechnisch verantwortliche Person) as defined in the Swiss legislation (HMG, AMBV). 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: oensuring that a quality management system is implemented and maintained; ofocusing on the management of authorized activities and the accuracy and quality of records; oensuring that initial and continuous training programs are implemented and maintained; ocoordinating and promptly performing any recall operations for medicinal products; oensuring that relevant customer complaints are dealt with effectively; oensuring that suppliers and customers are approved; oapproving any subcontracted activities which may impact on GDP; oensuring that self-inspections are performed at appropriate regular intervals following a pre-arranged program and necessary corrective measures are put in place; okeeping appropriate records of any delegated duties; odeciding on the final disposition of returned, rejected, recalled or falsified products; oapproving any returns to saleable stock; oensuring 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. oto acquire and maintain the necessary Ievel of expertise and experience through continuous education oto ensure that any medicinal products released onto the Swiss market meet the approved specifications and are produced in accordance with Good Manufacturing Practice (GMP). oto 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 . oassess the periodic quality reviews for all products approved for the Swiss market
Skills: QA,FVP
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
- The Deputy FvP is acting in absence of the FvP as "Responsible Person" (fachtechnisch verantwortliche Person) as defined in the Swiss legislation (HMG, AMBV).
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
Julia Ojeda