At a Glance
- Tasks: Support quality management and continuous improvement at the Indivior Fine Chemical Plant.
- Company: Join a leading pharmaceutical company focused on quality and compliance.
- Benefits: Competitive salary, career development opportunities, and a dynamic work environment.
- Other info: Opportunity to grow within a supportive team and engage with industry leaders.
- Why this job: Make a real impact on quality assurance in a hands-on role.
- Qualifications: Experience in quality management systems and strong analytical skills.
The predicted salary is between 40000 - 50000 £ per year.
- Quality Specialist – FCP
- Reports To: Head of QA & QC, FCP
- Position Summary
Embedded in the Quality Assurance team reporting to the Head of QA and QC, this hands‑on role tasks you with supporting management, maintenance, and continuous improvement of the quality system at the Indivior Fine Chemical Plant (FCP).
You will ensure compliance with Indivior Global Quality Policies, Gx P requirements, and the organisation's expectations regarding Quality KPI and metrics.
Additional duties include managing the vendor assurance programme, acting as a business partner to stakeholders, overseeing batch reviews to assure timely API release, generating, executing, reporting, and reviewing Gx P quality records, reporting and escalating potential issues and compliance risks, and executing internal and vendor audits.
You will also own the management of stability programmes, act as e DMS Document Controller and e QMS Super‑user, participate in quality and operational forums, supervise direct reports, and may act as deputy to the Head of QA & QC when authorised.
Essential Functions
- Manage and maintain the QMS to assure timely completion of document control activities, deviations, CAPA, change control, complaints, OOS/OOT, and APQRs to support KPI targets and Gx P compliance.
- Act as e QMS super‑user, providing technical support and training, and support administration of the system.
- Manage and report site quality KPIs and metrics, escalating trends and risks to senior leadership as required.
- Identify and implement initiatives for continuous improvement of quality and compliance standards across FCP operations.
- Organise and manage the site monthly quality meetings, providing status reviews, agendas, minutes, and tracking of agreed actions.
- Support and participate in quarterly Quality Management Review meetings, ensuring trends, risks and actions are documented and communicated.
- Support regulatory authority inspections and customer audits by maintaining inspection readiness, hosting audits and following up on post‑inspection/audit responses, commitments and actions.
- Draft and submit interim compliance reports to MHRA when required.
- Generate quality scorecard and attend monthly meeting.
- Manage the FCP self‑inspection programme through scheduling, performing and closing internal audits in partnership with internal and external functions.
- Act as deputy for the Head of QA & QC when authorised, for example supporting 3rd‑party API suppliers to prevent delays to manufacture and presenting at various forums such as the monthly FCP Leadership Quality Scorecard review.
- Perform any other duties required in the absence of the Head of QA & QC, FCP.
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Quality Specialist- FCP employer: PVH (Tommy Hilfiger/Calvin Klein)
Intapp is an exceptional employer, offering a dynamic work environment that fosters innovation and collaboration within the accounting and consulting sectors across EMEA. With a strong commitment to employee growth, Intapp provides ample opportunities for professional development and leadership coaching, ensuring that team members thrive in their careers while contributing to the company's strategic vision. The culture is built on accountability and high performance, making it an ideal place for those looking to make a significant impact in a rapidly evolving industry.
Contact Details:
PVH (Tommy Hilfiger/Calvin Klein) Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Quality Specialist- FCP
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We think you need these skills to ace Quality Specialist- FCP
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