Job Title: QC Technical Specialist
Contract: 9 months (+ possible extensions / become permanent)
Salary: £40,000 - £45,000 + project bonus
Synergy, part of SRG, offer a range of scientific solutions to customers in the Life Sciences sector. We offer a competitive salary, project related bonus, a range of excellent benefits and access to training & development opportunities within the role.
- Reporting to the QC Support Manager, you shall enhance practices and promote a culture which is consistent with cGMP, cGLP and Health & Safety within a pharmaceutical laboratory environment.
- To provide training support, technical knowledge and act as a scientific Subject Matter Expert (SME) for the Quality Control department, working closely with the internal Technical & Development Services teams to provide analytical support for new product introduction (NPI) and any technical issues.
Responsibilities and Accountabilities
- Act as the SME for a number of analytical techniques and procedures, providing training and audit support, as necessary.
- Perform test method verification and validation, including the issuance of protocols and reports.
- Support Technology Transfer for methods / processes being transferred to and from the department.
- Actively support the validation, verification and preventative maintenance of QC instruments.
- Manage the calibration of QC instruments and their certification in a timely manner, including CalMan updates.
- Undertake Laboratory Investigation Reports (LIRs), Deviations, Change Controls, CAPAs, Due Date Extension Requests and Effectiveness Reviews for related work.
- Manage the Reduced Testing program for Raw Materials and Packaging Componentry, ensuring an appropriate regime is maintained.
- Author Risk Assessments on an ad-hoc basis for processes, procedures and systems to ensure risks are identified and appropriately managed, including mitigation via corrective and preventive actions (CAPAs), where appropriate.
- >3 years' experience working at an advanced level with analytical techniques (traditional and instrumental) in a pharmaceutical GMP environment.
- GMP regulations for products produced, tested and marketed within the UK, EU and US.
- Significant laboratory equipment usage and maintenance experience.
- Advanced knowledge in validation and verification processes within pharmaceutical industry.
- Familiar with environmental, health & safety, regulatory and company standards.
If this role is of interest to you, (or you know anyone who might be suitable), please email your CV to Tom O'Neill at firstname.lastname@example.org and a time that is convenient for me to call you.
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