Senior QC Analyst

Adepto Technical Recruitment Ltd

Greater London

Presencial

GBP 55.000 - 75.000

Jornada completa

Hace 3 días
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Descripción de la vacante

Adepto Technical Recruitment Ltd is seeking a Senior QC Analyst for a GMP-regulated pharmaceutical manufacturing site on the North West London / Hertfordshire border. The role involves hands-on testing of raw materials, stability and finished products, with emphasis on chromatography and data integrity.

You will lead investigations, review data, and help ensure compliance and continuous improvement across the QA/QC laboratory.

Formación

  • Degree in Chemistry or related scientific field.
  • 3+ years' GMP pharmaceutical QC lab experience.
  • Strong hands-on experience with HPLC and/or GC.
  • Knowledge of BP, Ph. Eur., USP and JP pharmacopoeial testing.
  • Experience leading OOS/OOT investigations and CAPA.
  • Solid GMP, data integrity and method validation understanding.
  • Experience training or mentoring junior analysts.

Responsabilidades

  • Test raw materials, stability samples, in-process samples and finished products using validated methods.
  • Operate and troubleshoot analytical equipment (HPLC, GC, UV, FTIR, Raman).
  • Review analytical data, lab documentation and COAs.
  • Lead OOS/OOT, deviation and complaint investigations and implement CAPAs.
  • Write and review SOPs, test methods, protocols, reports and quality records.
  • Support method validation, verification and transfer.
  • Train and mentor junior analysts to competency sign-off.
  • Ensure GMP, data integrity and safety requirements are met.
  • Participate in audits and MHRA/client inspections and close actions.

Educación

Bachelor's degree in Chemistry or related scientific field

Herramientas

HPLC
GC
UV
FTIR
Raman

Descripción del empleo

Senior QC Analyst – Pharmaceutical Manufacturing

Location: North West London / Hertfordshire border | Permanent, full-time

The company

Our client is an MHRA-licensed UK manufacturer, working from a single modern site on the North West London / Hertfordshire border. They make pharmaceuticals and medical devices, both for their own brands and as a contract manufacturer for partner businesses. They're now looking for an experienced Senior QC Analyst to join their Quality Control laboratory. It's a senior, hands‑on role: you'll bring strong technical expertise, lead investigations, take ownership of equipment and documentation standards, and help train and develop junior analysts.

The role

You'll test raw materials, stability samples, in‑process samples and finished products, using validated and compendial methods. You'll be the lab's go‑to person for chromatography, investigations and documentation, and someone colleagues rely on for knowledge and support. Because it's a single site, you'll work closely with Production, QA and Technical teams, contribute to cross‑functional projects and see the impact of your work directly.

Key responsibilities
  • Testing raw materials, stability samples, in‑process samples and finished products to validated and compendial methods, delivering results on time and right first time
  • Operating and troubleshooting analytical equipment, including HPLC, GC, UV, FTIR and Raman, and keeping instruments available for the lab
  • Reviewing analytical data, laboratory documentation and Certificates of Analysis
  • Leading OOS, OOT, deviation and complaint investigations, using trend analysis and root cause analysis to put effective, lasting CAPAs in place
  • Writing and reviewing SOPs, test methods, protocols, reports and quality records
  • Supporting method validation, verification and transfer
  • Training and mentoring junior analysts through to competency sign‑off
  • Making sure work meets GMP, data integrity and laboratory safety requirements
  • Taking part in audits and MHRA and client inspections, and making sure resulting actions are closed on time
  • Identifying and leading continuous improvement initiatives in the lab
What success looks like
  • At least 95% of testing completed on time and at least 98% right first time
  • At least 95% instrument availability, with issues troubleshot promptly
  • At least 90% of OOS, OOT and deviation investigations closed on time
  • 100% training compliance, with trainees successfully signed off as competent
  • Zero critical GMP, data integrity or safety breaches, and zero critical audit findings
  • At least two improvement initiatives implemented each year
What you'll need
  • A degree in Chemistry, Pharmaceutical Sciences or a related scientific discipline
  • At least 3 years' experience in a GMP pharmaceutical QC laboratory
  • Strong hands‑on experience with HPLC and/or GC
  • Knowledge of BP, Ph. Eur., USP and JP pharmacopoeial testing
  • Experience leading OOS/OOT investigations, including root cause analysis and CAPA
  • A solid understanding of GMP, data integrity and method validation
  • Experience training or mentoring junior analysts
  • Strong analytical, problem‑solving and communication skills
What you'll bring

You take ownership of your work and deliver on your commitments. You're confident making timely, evidence‑based decisions, and you communicate clearly with colleagues across the site. You enjoy sharing your knowledge and supporting the team, adapt well to changing priorities, and are always looking for ways to improve how the lab works

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