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Senior Quality Specialist / QP Trainee

Location
Swindon, Wiltshire
Salary
£40,000 to £45,000
Job Type
Permanent
Posted
20 Jul 2022
Senior Quality Specialist/QP Trainee

This is a high-profiled role and involves day-to-day interactions with the Head of Quality and site QPs with the aim of supporting suitable candidates towards the attainment of QP eligibility.

Key Responsibilities

Managing and maintaining of the quality management system:

Corrective and preventative actions (CAPA)

Deviations

Change control

Supplier and customer complaints

Quality risk management (QRM)

Leading root cause analysis (RCA)

Collating QMS metrics and KPI data and presentation at quality management review (QMR) meetings

Liaising with Regulatory Authorities

Responsibilities

Provide QA oversight to production on day to day basis for quality issues. Assist in the creation/review of technical agreements, protocols, supplier agreements and quality risk assessments

Preparation of Master Batch Records for selected licensed medicines, Investigational Medicinal Products (IMP) and associated revisions.

Preparation and maintenance of Technical Dossier and Product Specification File (PSF), etc.

Liaising with Regulatory authorities addressing licencing issues, variations, etc.

Supporting Regulatory and Customer audits (front room/back room as appropriate).

Support the company internal audit, supplier audit and New Product Introduction (NPI) programmes, where required.

Author, Review and approve Standard Operating Procedures, CCs, RAs, PQRs and other controlled documents as required.

Proactive investigation/review of deviations, customer complaints, CAPAs, etc, ensuring they are suitably documented, investigated and closed out within agreed guidelines with issues escalated as required.

Prepares, reviews, updates and completes QMS processes (CC, CAPAS, Deviations, RAs, etc).

Training, coaching and supervision of production and QA staff in GMP/GDP, clinical trial / commercial packaging and labelling activities, creating training packages as appropriate.

Review of batch documentation for completed batches prior to QP / Head of Quality release.

Represent Quality Dept for site projects, incudes liaising with all departments and as appropriate with other sites.

Support the Head of Quality/QP/RP in the preparation and execution of the Quality Management Programme. Trend QMS metrics and interpret as appropriate.

Support the Responsible Persons and Qualified Persons in fulfilling their duties in accordance with Good Distribution Practice (GXP).

Support the Quality Specialist(s) and Quality Assurance Officer(s) carry out their responsibilities and duties, providing coaching/mentoring, as required.

Working independently of commercial pressures within the Organisation, keeping informed of regulatory changes in industry regulations and guidance. Keep knowledge up to date and current.

Deputise for the Head of Quality as necessary
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Details

  • Job Reference: 662717824-2
  • Date Posted: 20 July 2022
  • Recruiter: County Recruitment
    County Recruitment
  • Location: Swindon, Wiltshire
  • Salary: £40,000 to £45,000
  • Sector: Healthcare & Medical
  • Job Type: Permanent