QA Technical Specialist
- Reference: JLS QAS
- Location: Cardiff
- Salary: UPTO £37000
- Type: Full time
- Start: ASAP
Just Life Sciences are seeking a Technical/Quality Assurance Professional for their Global Pharma Client who are expanding rapidly through acquisition and organic growth.
We are looking for a candidate who has several years experience within a Technical QA role within a Pharmaceutical organisation.
Purpose of the role is
To provide technical Quality support to the Operational departments for new and ongoing projects.
Play a lead role in the interpretation of business and regulatory guidelines which assists with regulatory compliance.
To promote a sense of quality throughout the site business units so as to raise manufacturing/ development/clinical performance and eliminate waste caused by unnecessary compliance errors.
To conduct performance audits and follow up on actions within site business units.
Review and approve, for all areas, Master Batch Records (MBR), master despatch job cards, Technical specifications and addendums, master label approvals, returned Technical Specifications and Technical Agreements.
Write and review Drug Product Files (DPFs), Product Specification Files (PSFs)
QA approval of Item Masters.
Batch record compilation and regulatory checks.
Interpret PQR data.
Review and approve Deviations and Change Controls as needed.
To review non-compliance identified by audit, deviations and complaints, and use technical / professional judgment to make the appropriate product quality decisions (in association with site QP’s), and to initiate and promote quality improvements to prevent re-occurrence.
To ensure that products proposed for release by a site QP were manufactured in accordance with license requirements, clinical trial application and cGMP.
To assist with GMP training within the department and cross site.
• Review and improve departmental processes and eliminate waste.
• To identify self-development needs for future performance
• To undertake such tasks and to manage specific internal or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder’s capabilities and responsibilities.
Qualifications, Skills and Experience
Educated to degree level or equivalent in a science or quality assurance related discipline, and ideally be a member of a professional body as recognised by UK MHRA. (A lower aligned qualification plus significant QA pharma industry experience would also be considered).
The job holder will have significant experience in the pharmaceutical industry, with a diverse knowledge of various dosage form manufacturing and experience of staff supervision.
Experience of working within a Quality Department within a cGMP/pharma environment.
Excellent written and verbal communication skills are required by the job holder as in the course of the duties. The job holder will need to communicate with personnel outside of the Quality group, with external clients, regulatory bodies and consultants.
Previous experience of reviewing and approval of various QA Technical documentation, including but not limited to PSF, DPFs, and Technical Specifications.
The job holder will need to have excellent analytical problem solving abilities and be able to lead by example and get results through persuasion and co-operation.
Experience of GMP auditing to relevant quality standards with potential to perform audits.
- If this is you, or you are looking for other similar roles then please email your CV to justyn at justlifesciences dot com
Just Life Sciences
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