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QA Manager

Job Description:

Job Title: QA Manager
Location: Bridgend
Department: Quality
Work Pattern: 40 hours per week, Monday – Friday
Reporting to: Quality Director
Responsible for (staff): Senior QA Officers

Providing support to the Quality Director in developing and managing effective QMS, ensuring high quality levels are maintained and excellent customer service. Effective development of objectives to direct reports to ensure alignment to overall business strategy. Lead and assist in quality investigations, ensuring quality related incidents are controlled and appropriately investigated to root cause while identifying CAPA when required.

Essential Duties and Responsibilities:

  • Responsible for the effective deployment and development of the Quality Management System (QMS – electronic and paper-based elements) to ensure improvements in quality and customer services are realized and achieved.
  • Responsible for overseeing the effective management of the QMS including but not limited to deviations, customer complaints, CAPAs, audits, document control (SOPs), change control, validation and other duties as required.
  • Generate and report on QMS KPI’s to monitor compliance and effectiveness of the QMS.
  • Promote a culture of zero overdues and proactively follow up with staff to ensure completion of audits within timelines.
  • Write quality related standard operating procedures.
  • Provide quality assistance in investigation and resolution of internal and external quality issues applying risk management principles.
  • Provide QA and GMP related training when required.
  • Assessment of batch records (Pre-QP certification) when required.
  • Daily management of relevant quality personnel.
  • Manages and oversees regulatory inspections of PCI.
  • Manage the client audit schedule and where required, host client audits.
  • Manage supplier audit schedule ensuring all required audits are completed and reported in a timely fashion.
  • Review and approval of validation / qualification protocols and reports. Oversight of the site computer system validation requirements and ensuring compliance with site procedures.
  • To ensure Health and Safety levels are maintained, to keep up to date with new requirements and ensure they are implemented in a timely manner.
  • Accountable for the quality team member performance (for direct reports) providing direction to the Senior QA officers to ensure that quality objectives are deployed within the group and delivered on time.
  • To agree and work towards achievement of personal development goals
  • Where required, undertake departmental tasks and projects outside the job holder’s area of responsibility in line with departmental and site wide objectives.

Requirements:

Regulatory/Industry Responsibilities:

General

  • The job holder is responsible for adhering to PCI Standard Operating Procedures (SOPs), Health & Safety Rules, General Data Protection Regulations (GDPR), Good Manufacturing Practices (GMP) and other regulatory guidelines
  • Must have at least 5 years’ experience of working within a pharmaceutical company or related industry, preferably within a senior QA role.
  • Ideally the candidate will have experience with a wide range of medicinal product dosage forms.
  • Previous experience with investigational Medicinal Products is desirable.

Qualifications:

Required

  • Good GMP knowledge and experience of EU legislation and guidelines, experience with FDA GMP requirements CFR 210 and 211 and other regulatory guidelines.
  • Experience and knowledge of general management systems, ISO 9001, PS 9000, good IT skills with experience of eQMS, MS office software, MRP stock systems.
  • Good people management skills, the candidate should have previous experience of managing teams of personnel.

Preferred

  • A scientific degree in a life sciences subject (Chemistry, Biology, Pharmacy etc.) would be beneficial.

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