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QA Officer
This vacancy has now expired. Please see similar roles below...
Job Role:
- Provide day-to-day assistance for commercial QA activities associated with remote/virtual batch disposition.
- Ensure assigned tasks are performed in a timely manner to meet batch disposition, supply chain and all associated international GMP/GDP requirements.
Job Responsibilities:
- Batch Release 70% - To compile & review batch document sets for completeness & compliance to EU GMP, company internal requirements and regulatory dossier submissions
- To resolve manufacturing, testing, packaging and supply chain issues to support batch disposition
- To complete all relevant documentation to support the QP in the release of drug products
- To assist the certifying QP in the release of the drug product where required within company systems QA Support (Quality Systems)
- 30% - To assist in maintenance of quality systems including complaint handling, deviations/exception reporting, change control, supply agreements, document control, complaint handling, quality metrics reporting, temperature excursion resolution, document control and retention systems, training as determined by the Quality Manager.
- Project execution and support as required.
Skills, Education and Experience:
- Bachelors degree in a related scientific discipline with relevant experience (Preferably Biology / Chemistry/ Pharmacy/Life Sciences)
- Basic experience in pharmaceutical manufacturing, distribution and control measures
- Basic experience in Quality administered systems. Previous use of Trackwise QMS beneficial.
- Ability to apply technical knowledge and understanding to making appropriate and timely risk-based decisions.
- Able to demonstrate good planning and organisation skills
- Attention to detail and accuracy - able to follow verbal and written instruction (SOPs).
- Quality and process orientation and mindset
- Possession of good verbal and written communication skills
- Ability to accept responsibility and be pro-active within defined limits
- Sterile injectable manufacture
- Manufacture of novel dosage forms
- Secondary/outsourced packaging activities
- Global manufacture and supply chains
- New product launches & commercial supply chain
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Caleb Mensah on +44 203 854 1080 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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