QA Specialist Abingdon, England

Evotec

Full Time Abingdon, England 31889 - 37108 GBP ANNUAL Today

Job description

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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