Quality Assurance Specialist
Posted 6 days ago by PE Global
£29 Per hour
Inside
Remote
United Kingdom
Summary: PE Global is seeking a Quality Specialist for a leading multinational pharmaceutical client in Milton Keynes, offering a fully remote role. This initial 12-month contract position involves managing artwork changes for Contract Manufacturing Organizations (CMOs) in the EU. The candidate will be responsible for quality management and compliance within the pharmaceutical industry, requiring a background in science and experience in Quality/GMP or regulatory environments.
Key Responsibilities:
- Manage the operational implementation of artwork changes for several small and large molecule external CMOs in the EU.
- Act as the EMQ Site Point of Contact (SPOC).
- Maintain close contact with central Reliance QRD SPOC and global Artwork department.
- Coordinate with the responsible project contact at the CMO.
- Serve as the change task owner in Reliance (quality management system for change controls).
- Participate in stakeholder meetings.
- Ensure execution and timely closure of identified tasks.
- If applicable, develop new technical specifications with follow-up actions.
- Execute the Quality Representative role.
- Develop an artwork switch plan with relevant stakeholders.
- Escalate challenges and risks regarding project timelines and resources to CMO Governance.
Key Skills:
- Bachelor’s degree in science (Pharmacist, Engineer or equivalent).
- 3 years of experience in Quality/GMP or regulatory environment.
- Solid working knowledge of Good Manufacturing Practices (GMPs) in the pharmaceutical industry.
- Understanding of compliance, regulatory, or quality requirements in the pharmaceutical industry.
Salary (Rate): £29.33ph
City: undetermined
Country: United Kingdom
Working Arrangements: remote
IR35 Status: inside IR35
Seniority Level: undetermined
Industry: Other
PE Global is currently recruiting for a Quality Specialist for a leading multi-national Pharma client based in Milton Keynes. The role is fully remote. This is an initial 12 months contract position paying £17.79ph - £29.33ph PAYE depending on experience.
Duties of the role/Responsibilities
- Manage the operational implementation of artwork changes for several small and large molecule external Contract Manufacturing Organizations (CMO’s) in the EU covering finished product packaging and quality as well as supply chain related adaptations.
- Be the EMQ Site Point of Contact (SPOC)
- Be in close contact with central Reliance QRD SPOC and in close contact with global Artwork department (GRA Operations)
- Be in close contact with the responsible project contact at the CMO
- Be the change task owner in Reliance (quality management system for change controls)
- Take part in stakeholder meetings
- Execution and timely closure of identified task
- If applicable develop new technical specification with follow up actions
- Execute the Quality Representative role
- Develop an artwork switch plan together with the global artwork department, the QRD Reliance Manager, the Global Supplier Management (GSM) contact and the project contact at the CMO for the impacted products
- Escalate challenges and risks with respect to project timelines and resources to CMO Governance
Education/Experience
- You have a Bachelor’s degree in science (Pharmacist, Engineer or equivalent) or something similar
- 3 Years experience in Quality/GMP or Regulatory environment.
- You have a solid working knowledge of the Good Manufacturing Practices (GMPs) in pharmaceutical industry
- You have a solid working knowledge about compliance, regulatory or quality requirements in the pharmaceutical industry
Interested candidates should submit an updated CV. Please click the link below to apply, or send an up to date CV to “anett@peglobal.co.uk”
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***