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.