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Qualified person (qp) – pharmaceutical manufacturing & quality

Newcastle Upon Tyne (Tyne and Wear)
Elvis Eckardt Recruitment
Biostatistician
Posted: 8h ago
Offer description

Qualified Person (QP) – Pharmaceutical Manufacturing & Quality


Industry: Global Pharmaceuticals / Life Sciences

Location: London, United Kingdom (On-site / Manufacturing & Corporate Quality Office)

Type: Full-Time, Permanent

Salary Band: £90,000 – £110,000 + Benefits

Experience Level: Senior (8–15 Years)


The Role (Why This Exists): We are supporting a global pharmaceutical organisation operating in highly regulated UK and EU markets, seeking a Qualified Person (QP) to take full legal and technical ownership of batch certification, GMP compliance, and regulatory alignment across UK and European operations.


This is a hands-on, accountable QP role where you act as the final legal authority between manufacturing and patient release.


What You’ll Be Accountable For:


Batch Certification & Manufacturing Oversight:

* Legally certify pharmaceutical batches in line with UK law and EU Directives
* Ensure manufacturing and testing activities comply with GMP and Marketing Authorisations
* Oversee internal and third-party manufacturing partners


Quality Systems & Compliance Leadership:

* Own and maintain the Quality Management System (QMS)
* Lead governance of:
* Deviations
* CAPAs
* Change Controls
* Risk Assessments
* Annual Product Reviews (APR)
* Self-Inspections & Audits


Regulatory & Authority Engagement:

* Act as a senior quality interface with MHRA and EU regulatory bodies
* Support inspections, manufacturing line approvals, and regulatory submissions


Cross-Functional Leadership:

* Partner with QA, Manufacturing, Regulatory Affairs, and Supply Chain teams
* Lead GMP training and SOP development across UK/EU operations


Quality Risk & Patient Safety:

* Own recall processes and escalation pathways
* Proactively identify and mitigate quality risks impacting patient safety


Must-Haves (Non-Negotiable):

* Eligible to act as a Qualified Person under UK law (Directive 2001/83/EC)
* 4–5+ years operating as a named QP in regulated pharmaceutical environments
* Degree in Pharmacy, Chemistry, Biology, or related life sciences
* Deep hands-on experience with: GMP manufacturing operations; Batch certification and regulatory documentation; Pharmaceutical Quality Systems
* Experience within large or multi-site pharmaceutical organisations


Nice-to-Haves:

* UK/EU multi-site manufacturing oversight
* Third-party manufacturer and Quality Agreement management
* Regulatory audit leadership


Work Environment:

* On-site role spanning manufacturing facilities and corporate quality office (London)
* Close collaboration with production, QA, regulatory, and leadership teams
* 2–3 stage interview process, including technical and compliance assessment


Compliance & Eligibility:

* UK Citizens / Permanent Right to Work required
* Notice Period: 30–45 days preferred
* This is a site-based role (not remote / hybrid)


Application Process: To apply, please submit your CV and a cover letter detailing your relevant experience and qualifications for the role. Applications will be reviewed on a rolling basis, so early submissions are encouraged.


Equal Opportunity Employer: We value diversity and are committed to creating an inclusive work environment. We encourage applicants from all backgrounds to apply.


Contact: Elvis Eckardt

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Home > Jobs > Science jobs > Biostatistician jobs > Biostatistician jobs in Newcastle Upon Tyne (Tyne and Wear) > Qualified Person (QP) – Pharmaceutical Manufacturing & Quality

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