Quality Specialist Iii

5 months ago

Abingdon, United Kingdom Evotec Full time

Our Company

Evotec, Aptuit’ s parent company, is a leader in the discovery and development of novel therapeutics of all modalities with operational sites in the UK, Europe (Germany, Italy and France) as well as the US. Aptuit Oxford provides integrated Chemistry, Manufacturing and Control capabilities to fully support drug substance development and GMP manufacturing on both laboratory and commercial scales for Active Pharmaceutical Ingredients.

An exciting opportunity has arisen to join our fast-paced Compliance & Quality Systems team. A key focus of the role is supporting QA activities to ensure the site’s compliance to GMP; activities include, GMP document management duties and providing support in the maintenance of the Archive facilities.

Reporting Strategy
- Line Manager - QA Senior Manager

Primary Responsibilities
- To take a leading role in executing and supporting the day-to-day running of the department
- Provide Quality Assurance guidance and coaching to other departments to ensure compliance to Aptuit policy, best practice and cGMP
- Produce results inline with Aptuit policy, best practice and cGMP in the desired timeframes as directed by their line manager

**Job Description**:

- Consistently performs the tasks that are assigned to their role within Quality Assurance.
- Consistency in results generated and routine performance to inspire trust and confidence in the work they are requested and expected to perform.
- Comprehensive understanding of cGMP procedures, how they relate in the larger regulatory environment and an ability to place them in context.
- Provide QA support to API Manufacturing, Facilities Management & Engineering and Quality Control ensuring that work generated with GMP areas meets current regulatory requirements
- Review and approve deviations, complaint and OOS investigations in accordance with company procedures
- Maintain relevant quality logs and track quality metrics, as needed
- Identifies & takes action to resolve issues as they arise across site. Adopts a leading role in the root cause analysis and driving effective CAPA to prevent recurrence
- Follow up on the implementation of corrective and preventative actions and the evaluation of CAPA effectiveness
- Identifies and prioritises assigned work and that of junior members of the QA team, & focuses on priorities with mínimal guidance
- Generation and review of Quality Assurance procedures and other documentation.
- Support in the inspections by regulatory authorities and clients; Support in the drafting of the responses to the findings and their subsequent implementation
- Project involvement - arranges and participates in meetings and project team activities
- Builds effective working relationships with members of other departments to ensure successful completion of tasks in line with business requirements through a partnership approach.
- Maintain and share with colleagues as appropriate, personal knowledge of GMP and current industry practice.
- Seeks continuous quality and process improvement in QA and site practices.
- Attend training as required to develop knowledge and skills. Commits time & effort to learn new skills or approaches.
- Deputises for QA Senior Manager as appropriate.

Key Tasks
- Maintenance of QMS including QA review/approval of change controls, deviations, CAPAs and risk assessments
- Participate in writing/reviewing/approving risk assessment documents to support compliance related topics
- Lead internal audits and supporting external inspections (both client and regulatory)
- Participate in the periodic document review process, i.e. conduct reviews of Quality owned procedural documentation to ascertain if updates are required
- Participate in Supplier Assurance activities and approval of supplier questionnaires
- Participate in the QA review/approval of microbiological testing results used to support the monitoring of the purified water plants, including annual trending reports
- Participate in the QA review/approval of routine environmental monitoring reports, including annual trending reports
- Participate in the QA review/approval of pest control reports

Other skills or attributes
- Excellent communication skills - clear, and timely written & verbal communication.
- High attention to detail which supports a “right first time” culture.
- Comprehensive knowledge and technical competence in Quality Assurance
- Excellent time management/organizational skills in order to achieve planning/deadlines
- Be resilient and resourceful taking a flexible approach and demonstrate initiative.
- An ability to work independently or as part of a team.
- Ability to actively participate in meetings and support QA projects.
- Exhibits excellent critical thinking, the ability to risk assess problems and prioritize actions according to risk, and Root Cause Analysis.
- An ability to generate and implement solutions to both department and site issues.

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