Quality Assurance Specialist

JR United Kingdom; Glasgow; On-site; GBP 30,000 - 50,000; Full time

Job summary

A leading quality assurance company is looking for a Quality Specialist in Glasgow. This role involves ensuring compliance with GMP and supporting the Quality Assurance team in various administrative and technical duties. Candidates should have a science-related degree and knowledge of regulatory requirements. The position requires attention to detail and the ability to prioritize tasks. A flexible work schedule is offered.

Qualifications

• Broad understanding of regulatory requirements and GMP.
• Proven experience in a Quality environment is advantageous.

Responsibilities

• Document all work adhering to GMP and departmental procedures.
• Conduct self-inspections to ensure compliance with QMS.
• Support client audits and regulatory inspections.

Skills

Knowledge of GMP

Regulatory requirements understanding

Experience in aseptic manufacturing

Ability to prioritize tasks

Education

Science related degree

Job description

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We have an opportunity to join our Quality Assurance team based at our Glasgow site in the role of Quality Specialist. 12 month FTC (Mat Cover).

This is a technical position, with responsibility for providing support functions for the QA group and ensuring this work is performed in an organised and timely manner. Additionally, performs administrative and technical Quality Assurance duties, whilst adhering to GMP, COSHH and Health and Safety regulations.

Quality Assurance operates as a support function for site, ensuring that all activities adhere to the requirements of the Quality Management System and that the site operates in compliance with current GMP. All work is performed within the Glasgow facility and operates to ensure that sterile products are manufactured to GMP in a consistent manner

Responsibilities include but not limited:

• Documents and reports of all work in adherence with GMP and departmental procedures.
• Performs batch review within the designated timelines described in departmental KPI.
• Authors and reviews SOPs.
• Reviews change controls, CAPAs and deviations. Provides feedback / corrections to authors and escalates concerns to QA Manager where necessary.
• Raise CAPA, approve category CA/PA and review for completion CAPA and support the completion of actions through liaison with other departments.
• Represent Quality Assurance in continuous improvement projects ensuring that change is performed in accordance with GMP, site procedures and industry regulations and guidelines.
• Identifies and performs personal development in line with agreed and documented annual goals including successful completion of internal and external training course.
• Supports the completion of administration tasks associated with of supplier certification.
• Acts as a support to client audits and regulatory inspections, helping with technical support to the audit team and responding to requests for documentation and information.
• Works to a schedule as defined by the QA Manager.
• Conducts self-inspection’s / audits to ensure compliance with Quality Management System procedures and GMP regulations.
• Ensuring that a timely and effective communication and escalation of quality issues to the appropriate levels of management.
• Carries out site internal audits and identifies areas of GMP improvement during their daily duties, and participate in client projects as a QA representative.
• Carries out training for QMS activities as defined by line management.
• Actively participle in achieving the QA/Quality KPI’s and participate in the QA on-call rotation as required.

Responsible for identifying corrections necessary to batch records or other QMS documents and making suggestions to operational or laboratory functions to enhance GMP compliance.

Responsible for reviewing and progressing Minor/Major category deviations and CAPA in reasonable time frames.

Responsible for providing advice based on GMP and scientific rational to departments when designated the QA individual ‘On call’ or escalating to QA Manager, where appropriate.

Skills and Qualifications:

• Hold a Science related degree qualification
• Wide breadth and depth of knowledge and understanding in regulatory requirements and GMP, ICH, COSHH etc.
• Knowledge and experience of UK / EU / US GMP and Quality Assurance.
• Ideally Experience in an aseptic manufacturing environment.
• Prioritise tasks and meet deadlines.
• Proven experience within a similar Quality environment is advantageous

Hours: 8-hour shift including breaks, with a flexible starting and finish time between 7:30am and 6:30pm, Monday to Friday (overtime and on call available)

Curia (Scotland) Limited is committed to fostering a diverse and inclusive workplace where all perspectives are valued and respected. We proudly support equal opportunity and are an affirmative-action employer, welcoming applications from all qualified individuals. We consider all applicants for employment without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, genetic information, disability, veteran status, or any other protected status.