Senior QA Technician
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Job Description
Key Roles and Responsibilities:-
- Support disposition through review of manufacturing, laboratory and associated documentation prior to QP review and disposition of final products. Where potential issues exist, these are to be highlighted to the QA Team Leader / QA Manager.
- Review the relevant documentation relating to incoming raw materials including approval of material specifications and material documentation packs
- Act as department point of contact for SAP and material clearance, whilst providing oversight of Technician team workload and highlighting any issues to QA Team Leaders / QA Manager as necessary.
- Support the QMS of the site by completion of allocated change control action and CAPA records through implementation / approval.
- Generating and checking of labels for product and status as required
- Support manufacturing activities by providing line clearance as required.
- Shadow lead QA Officers on client calls to develop knowledge and understanding of projects as well as acquiring new skills for own career progression
- Support QA Officers with documentation / procedural updates from new project sitting
Competencies:-
- Attention to detail
- Good communication skills, both verbal and written
- Good organisation skills
- Ability to work effectively individually and as part of a team
- Ability to analyse data and information to make considered decisions
- The ability to identify root cause of problems to determine appropriate solutions
- Ability to prioritise workload to ensure timelines are met
- Ability to follow instruction accurately
- Ability to escalate issues as appropriate
Qualifications
Essential Qualification and Experience:-
- BSc in a relevant Scientific discipline or equivalent.
- A minimum of 3 years' experience within a cGMP environment manufacturing Active Pharmaceutical Ingredients is required.
- A College/University qualification in a scientific subject is required.
- Experience in dealing with quality assurance, analytical chemistry, development, and manufacturing groups is beneficial