QA Specialist

2 weeks ago

Abingdon, United Kingdom Evotec Full time

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.

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.
- 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.

**Job Types**: Full-time, Permanent

**Salary**: £40,000.00 per year

**Benefits**:

- Casual dress
- Company events
- Company pension
- Cycle to work scheme
- Discounted or free food
- Employee discount
- Flexitime
- Free parking
- On-site parking
- Private dental insurance
- Private medical insurance
- Referral programme
- Wellness programme
- Work from home

Schedule:

- Flexitime

Supplemental pay types:

- Performance bonus
- Yearly bonus

Ability to commute/relocate:

- Abingdon: reliably commute or plan to relocate before starting work (required)

Work Location: In person

Reference ID: 07602

Flextime

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