Specialist Qc

2 weeks ago

Liverpool, United Kingdom SRG Full time

**Job Title**:Specialist QC
- **Location**:Speke, Liverpool.
- **Contract**:18 months
- **Salary**:circa 40k
- **Hours: Mon -**Thurs 08.00 - 16.45, Fri 08.00 - 13.00 (37.5 hours)

SRG are currently working with a global pharmaceutical company based in Liverpool, looking for a Specialist QC Scientist to join the team.

**Position Summary**:
Within this role you will provide technical and analytical support to the Quality Control function.

Support includes instrumentation and methodology troubleshooting, non-routine analysis, and the evaluation, exploitation and implementation of new technology. Role holder leads significant Quality Control investigations and change programs including introductionof new methods and technologies and is responsible for review and approval of QC documents as appropriate.

Specialist is expected to play a key role in coaching and mentoring and developing other team members and working cross departmentally to support the overall QC organisation.

Responsibility for issue resolution both within and outside the team, removing obstacles and understanding issues whilst guiding solutions.

**Major Duties and Responsibilities**:

- Provides expert technical knowledge and acts a QC representative in meetings on and off site.
- Provide leadership and technical knowledge, authors/ review/ approves QC documentation, Out Of Specifications (OOS) investigations, Non-conformance investigations and technical queries locally and for Global collaborative partners as required.
- To monitor and technically support the company procedures e.g. excursions and investigations.
- Responsible for review and approval of all technical documents and ensuring LRP/CofA are available for batch release timelines..
- Own, review and approval of change control and deviation investigations as required
- Drives and leads change management, projects and continuous improvement by supporting the implementation of new technology through method validation activities and the analytical technology transfer of QC methodology into and out of Operations.
- Improve technical capability within the team through support, training and coaching/mentoring
- Identifies, introduces and embeds new technology/systems into the QC Function ensuring that the QC function remains contemporary and competitive.
- Compiles and provides communications and status updates to QC Management Team and key stakeholders
- Support internal and external regulatory audits
- Author and review of regulatory documents and submissions.
- Coordinates, champions, leads and participates in continuous improvement and LEAN processes and initiatives to support scorecard deliverables with appropriate escalation in line with AZ values and behaviours.
- Supplier relationship management with key Outside Testing Laboratories as appropriate.
- Collaborates and works across QC functions to ensure specialist resource to support all critical QC activities.
- Participates in Specialist forums to Share and standardise best practice and improve QC technical agility.

**Essential Requirements / Qualifications**:

- Qualified to degree level/or equivalent in a scientific discipline.
- Technical SME in a QC Discipline.
- Effective problem-solving skills.
- Sound knowledge and understanding of the principles and concepts of compliance management and Good Manufacturing Practice / Good Laboratory Practice
- qPCR experience

**Desirable requirements**:

- Biopharmaceutical industry experience.
- Project management and influencing skills.
- Lead Investigator expertise required
- Significant experience in QC laboratory environment
- qPCR experience,**developing and validating** GMP assays in the qPCR realm
- Next Generation Sequencing experience is advantageous

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.

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