Job Description
Job Description
We take great pride in our vast range of chemical and biochemical products and our high standards can only be maintained through great people who share our values and desire to do the very best job possible every day.
Main Purpose of the Job
Named on the API an MIA(IMP) licences and accountable for the quality assurance of the site, ensuring product safety and efficacy, and maintaining compliance with both European and FDA GMP regulations and Biosynth’s global standards. The Quality Assurance Manager will report into the global head of quality and play a part of the global harmonisation and have a pivotal role in Biosynth’s constant strive for quality improvement.
Key Responsibilities
- Named on the licence as Quality Controller for both the API and MIP licence
- Improve and maintain all aspects of the Pharmaceutical Quality System (PQS) ensuring efficient and effective operation.
- As quality manager will have final say on approving or rejecting starting and finished materials, packaging materials, intermediate, bulk and finished products and approval of batch records.
- Ensuring that the required initial and continuing training of their department personnel is carried out and adapted according to need.
- Maintain the sites ISO certification (9001) and transition to into a companywide certification
- Ensuring the qualification, maintenance, appropriate validations of their department, premises and equipment
- Ensuring that all necessary testing is carried out, approving specifications, sampling instructions, test methods and other quality control procedures.
- Active contribution in the global harmonization processes and documentation of all Biosynth GMP sites.
- Ensure compliance with industry standards, regulatory requirements, and company quality objectives.
- Drive investigations into customer complaints, non-conforming products, and deviations.
- Expert Knowledge of Development of Quality Assurance procedures and guidelines.
- QC analytical and microbiological oversite and team development.
- Implement a robust QPS system for GMP and maintain ISO 9001 status.
- Ensure MHRA and customer audits are prepared and executed with no major findings.
- QA inputs to all project work ensuring timelines are met.
- Provide leadership to the QA and QC departments.
- Implement CCS for the facility.
Essential Requirements
- Degree in Pharmacy, Chemistry, Biology, or related field
- In-depth knowledge of Pharmaceutical quality systems and relevant regulations (e.g., FDA, EMA, ICH, ISO 9001)
- QP eligible or QP in training
- 3+ years in a senior quality role
- 1+ year leading quality department
- Clear and succinct communication
- Analytical
- Continuous improvement
- Pragmatic
- Analytical and problem-solving ability.
- Planning and project management skills
- The ability to facilitate change
About us
Biosynth® is an innovative life sciences reagents, custom synthesis and manufacturing services company headquartered in Staad, Switzerland. We are by scientists, for scientists, securing supply chains with consistent quality, across the globe. As a trusted supplier, manufacturer and partner to the pharmaceutical, life science and diagnostic industries, as well as food, agrochemical and cosmetic customers, we have facilities on three continents and a rapid global distribution network. Our main production laboratories are located in Switzerland, the UK, Slovakia and China, with peptide and antibody production in the US, the Netherlands. Enzyme projects are based in Austria, bioconjugation project are based in Germany and biological IVD reagents in Ireland
Recruitment agencies - we are unable to accept unsolicited CVs and communications from external recruiters. We do not use recruitment agencies to recruit for our roles.