QA Specialist

QA Specialist Bedford, England

Central Pharma
Full Time Bedford, England 30000 - 35000 GBP ANNUAL Today
Job description

QA Specialist Job Description

Role Responsibilities

  • To ensure all Central Pharma obligations are being met in terms of Technical Agreements, Manufacturer’s and Importer’s licence and Wholesale Dealer’s Licence.
  • Ensure the PQMS is maintained in a state of control across all Central Pharma sites.
  • Ensure activities performed by the Quality department are performed in accordance with GMP, GDP, ISO 9001 and ISO 13485 requirements.
  • To control and preparation of PQMS documents including SOPs, validations, complaints, change controls, CAPAs, and deviations.
  • To support regulatory audits including MHRA, and Home Office inspections.
  • To conduct training of staff as and when required.
  • To create, execute, and review of validation protocols, reports, and spreadsheets.
  • To create and maintain validation master plans for all sites.
  • To coordinate activities between production, customer services, warehouse and QA departments to ensure KPIs, deadlines and expectations are met.
  • To investigate deviations, complaints, determine root causes and implement effective CAPA actions.
  • To communicate with customers and suppliers as and when required.
  • To review batch documentation, CoAs, Analytical and micro results.
  • To review temperature data prior to product release.
  • To participate self-inspection program.
  • To be part of supplier assessment team and conduct external supplier audits.
  • To represent Central Pharma at customer audits and meetings.
  • Proactively contribute to creating a good team atmosphere.
  • Any other such duties that from time to time may be required.

The above is not a complete and exhaustive list and other duties may be required to be undertaken as and when necessary.

Experience, Skills, and Competencies:

· Batchelor’s degree in science or related discipline.

· Minimum 3 years’ experience working within a pharmaceutical GMP/ GDP environment.

· Excellent communication skills.

· Ability to deliver effective presentations.

· Competent on Word, Excel, and PowerPoint.

· Professional handling of all internal and external communications with regards to quality.

· Good knowledge of pharmaceutical regulatory updates.

· Good attention to detail in day-to-day activities.

· Strong organisational and time management skills for the control of self-workload.

· Good team player.

· Strong in project completion and CAPA closeout.

· Flexible in supporting business needs.

· Uses initiatives to drive improvements.

Job Types: Full-time, Permanent

Salary: £30,000.00-£35,000.00 per year

Benefits:

  • Bereavement leave
  • Company pension
  • Free parking
  • On-site parking
  • Sick pay

Schedule:

  • Monday to Friday

Ability to commute/relocate:

  • Bedford: reliably commute or plan to relocate before starting work (required)

Work Location: In person

Application deadline: 10/09/2023

QA Specialist
Central Pharma

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