Quality GDP Manager / Responsible Person
Location: United KingdomSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical and Biotechnology organisation, based in City of London United Kingdom.
Responsible Person (RP)
- Ensures GDP requirements applicable to the activities managed by company; Corporate procedural documents related to GDP and any update from regulations are communicated to relevant departments.
- Ensures that medicines are supplied and traded according to GDP.
- Supports the organisation in fighting counterfeit medicinal products according to guidelines issued by the relevant UK and EU authorities and the agreements in place.
- Negotiates Quality Agreements including responsibilities relating to wholesale distribution and/or product transportation.
- Ensures that suppliers and customers are qualified, Bona Fides checks are performed for markets.
- Ensures that self-inspections are performed and inspection readiness.
- Assures the establishment license is maintained.
- Lead GDP Management review activities including GDP metric review.
- Coordinate and promptly perform any recall operations for medicinal products.
- Approves any returns to saleable stock and trend stock returns.
- Approves procedures applicable to wholesale distributor's activities.
- Ensures applicable documentation is complete and current, and delegation documentation is maintained when required.
- Previous experience as Responsible Person or Qualified Person as well as understanding of the UK laws
- Minimum 5 years of experience in the pharmaceutical industry, preferably in Quality, Manufacturing Technology, Regulatory or a position within a Health Authority Agency.
- Proficient in cGMPs, cGDPs and regulations promulgated by the FDA, EMA or equivalent regulatory Agencies.
- Extensive experience and technical knowledge in wholesale distribution operations which enables firsthand knowledge of good distribution practice, transportation, quality assurance. Demonstrated knowledge of and training in GDP.
- In depth knowledge of GDP regulations pertinent to the USA, EU and other international markets.
- Direct experience interacting, effectively communicating with Health Authorities; managing Health Authority inspections.
- Extensive experience and technical knowledge in chemical, biological and/or pharmaceutical operations which enables firsthand knowledge of manufacturing, quality control, quality assurance, regulatory affairs/sciences.
- Ability to deal and influence effectively all levels of management to ensure that decisions regarding quality are taken independently and build relationships, partnerships and influence and/or enforce quality decisions.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Riko Arends.
The Company
Our clients in the UK are looking for Quality GDP Manager / Responsible Person at multiple locations in the UKRole Description
Quality Good Distribution Practices Manager (GDP)Responsible Person (RP)
Responsibilities
- Ensures that a quality management system is implemented and maintained. The systems, procedures and responsibilities within the Quality Management System are defined in a Quality Manual with focus on GDP.- Ensures GDP requirements applicable to the activities managed by company; Corporate procedural documents related to GDP and any update from regulations are communicated to relevant departments.
- Ensures that medicines are supplied and traded according to GDP.
- Supports the organisation in fighting counterfeit medicinal products according to guidelines issued by the relevant UK and EU authorities and the agreements in place.
- Negotiates Quality Agreements including responsibilities relating to wholesale distribution and/or product transportation.
- Ensures that suppliers and customers are qualified, Bona Fides checks are performed for markets.
- Ensures that self-inspections are performed and inspection readiness.
- Assures the establishment license is maintained.
- Lead GDP Management review activities including GDP metric review.
- Coordinate and promptly perform any recall operations for medicinal products.
- Approves any returns to saleable stock and trend stock returns.
- Approves procedures applicable to wholesale distributor's activities.
- Ensures applicable documentation is complete and current, and delegation documentation is maintained when required.
Requirements
- Bachelor degree in a relevant scientific discipline e.g. Biochemistry, Microbiology, Pharmacy, Biological Sciences or related Pharmaceutical Science is required.- Previous experience as Responsible Person or Qualified Person as well as understanding of the UK laws
- Minimum 5 years of experience in the pharmaceutical industry, preferably in Quality, Manufacturing Technology, Regulatory or a position within a Health Authority Agency.
- Proficient in cGMPs, cGDPs and regulations promulgated by the FDA, EMA or equivalent regulatory Agencies.
- Extensive experience and technical knowledge in wholesale distribution operations which enables firsthand knowledge of good distribution practice, transportation, quality assurance. Demonstrated knowledge of and training in GDP.
- In depth knowledge of GDP regulations pertinent to the USA, EU and other international markets.
- Direct experience interacting, effectively communicating with Health Authorities; managing Health Authority inspections.
- Extensive experience and technical knowledge in chemical, biological and/or pharmaceutical operations which enables firsthand knowledge of manufacturing, quality control, quality assurance, regulatory affairs/sciences.
- Ability to deal and influence effectively all levels of management to ensure that decisions regarding quality are taken independently and build relationships, partnerships and influence and/or enforce quality decisions.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Riko Arends.
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