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🇬🇧 United Kingdom Corridor 🛡️ Verified Employer Direct Placement

QA Specialist

🏢 Evotec 📍 Abingdon, England 💼 Company - Public
Currency:
£31,889 - £37,108
£2,657 - £3,092 / mo
Verified Corporate Employer (Authorized Corporate Employer)

This vacancy is published by an accredited employer with authorized corporate payroll and standard compliance adherence.

Transatlantic Cost of Living & Purchasing Power Benchmark

Verified Analytics
Location Base
Abingdon, England
Tier-1 UK Economic Zone
Est. Take-Home Pay
68% - 74% (After PAYE & NI)
Single tax filer baseline
Transatlantic Parity
1.0 GBP ≈ $1.28 USD Living Standard
Direct corporate benchmark

Position Overview & Specifications

We are currently recruiting an experienced QA Specialist to join the team at Milton Park, Abingdon, Oxfordshire. This is a permanent position to start ASAP.
As a member company of Evotec, Aptuit offers a complete set of integrated drug development solutions by applying scientific excellence, outstanding service and a team of some of the foremost scientific professionals in the industry.
Evotec is a drug discovery alliance and development partnership company focused on rapidly progressing innovative product approaches with leading pharmaceutical and biotechnology companies, academics, patient advocacy groups and venture capitalists.
Primary Responsibilities
  • Provides the required support for the areas API Production, API Chemistry, QC, Warehouse and Engineering.
  • Provide Quality oversight activities across the site including the assurance of facility, equipment calibration and maintenance, and provide technical GMP support to the other departments and Clients as required.
  • Identify issues and participate in the investigation of problems to identify root causes associated with deviations and OOS investigations. Work with other departments to find resolutions to any non-conformances identified.
  • Aid in the identification of inefficient processes and introduction of lean alternatives whilst maintaining compliance.
  • Responsible for decisions related to GMP compliance in relation to the work, dealing with the challenges associated with a multi-client driven business, and require the energy and enthusiasm to play a contributory part in a diverse team.
  • Ensure activities within the area are aligned with the company policies, best practices and are cGMP compliant.
  • Provide advice to other departments to ensure their compliance to company policies, best practice and cGMP.
  • Liaise with members of other departments to ensure timely and successful completion of tasks.
  • Liaises with members of other departments at all levels to resolve any Quality related issues.
Job Role
  • Involved in the review of manufacturing batch records, cleaning documentation and associated analytical data.
  • Prepare product quality reviews (PQRs).
  • Project involvement - arrange and participate in meetings and project team activities as per the requirements of the active/new projects.
  • Provides the required support during client audits and regulatory inspections.
  • Identify issues and participate in the investigation of problems to identify root causes associated with deviations and investigations (OOSs, Lab investigations, etc…).
  • Aid in the identification of inefficient processes and introduction of lean alternatives whilst maintaining compliance.
  • Prepare COA/GMP statements, BSE/TSE and other certifications and statement of results.
  • Raw material code assignment and risk assessments.
  • Manufacturing cleaning and decontamination certificates.
  • Review of raw data, including logbooks, to ensure adherence to cGMP and good documentation practices.
  • Review and approval of production equipment (cleaning, changes, deviations, qualifications, and calibration).
  • Monitor water plant results and generate annual environmental monitoring reports.
  • Review and approve QC method validation, stability protocols and reports, assess the qualification requirements for equipment changes and routine calibration data.
Other skills or attributes
  • BSc or higher in a scientific area.
  • Lean six sigma training (preferred).
  • Strong communication skills with the ability to interact with all levels throughout the organization.
  • Excellent time management/organisational skills.
  • Experience working for a technical area (pref. > 2 years) and for QA (at least 1 year).
  • Good knowledge of cGMP and other regulatory requirements (ICH, EU, CFR), how they relate in the larger regulatory environment and an ability to place them in context.
  • Sound Data Integrity knowledge/experience.
  • Creative, innovative, proactive and dynamic.
  • Excellent teamwork (work effectively and efficiently in a cross functional team environment).
  • Ability to coordinate multiple priorities in a fast-paced environment.
  • Solid organizational, analytical and problem-solving skills, with the ability to troubleshoot and resolve problems – Root cause analysis training and experience preferred.
  • Able to suggest innovative and practical ideas/solutions to problems.
  • Excellent interpersonal skills and flexibility.
  • Excellent critical thinking, the ability to risk assess problems and prioritise actions according to risk, and Root Cause Analysis.
FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.
ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.
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Candidate Selection & Onboarding Process

1

Application & Resume Screening

Submit your tailored CV/Resume directly to the talent acquisition portal.

2

Technical & Competency Interviews

Virtual interviews with the hiring manager and multidisciplinary team.

3

Formal Offer & Benefits Negotiation

Written agreement outlining compensation, equity, retirement vesting, and relocation allowances.

4

Onboarding & Corporate Integration

Equipment provisioning, team orientation, and commencement of duties.

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Hiring Organization
Evotec

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Location: Abingdon, England
Eligibility: Verified Employer Direct Placement
Schedule: Company - Public
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