Manufacturing Operations

Quality Compliance Auditor

Not Specified

International Pharmaceutical Manufacturer requires a Quality Compliance Auditor, the role requires regular International and European travel.

About the role:

  • Complete audits and assessments of suppliers and service providers.
  • Provide feedback to the Head of Supplier and Customer Quality Assurance on the compliance of suppliers and service providers with respect to regulatory requirements and Technical and Quality Agreements and Specifications.
  • Identify gaps, communicate any observations noted and review responses so that a positive working relationship with suppliers and service providers is maintained.
  • Write and review Technical and Quality Agreements to ensure robust partnerships exist with suppliers and service providers.
  • Review and respond to customer and third-party audit and self-assessment questionnaires.
  • Perform internal audits and provide feedback to the Head of Supplier and Customer Quality Assurance on the GxP compliance of systems and processes. Identify gaps and facilitate improvements to systems and processes to ensure adherence to current GMP guidelines.
  • To ensure activities meet the requirements of current GxP regulations by reviewing updates to Pharmacopoeial and GxP requirements.

Duties may include:

  • Assist in the planning and execution of the supplier audit program.
  • Complete audits and assessments of suppliers and service providers with respect to regulatory requirements and Quality Agreements and Specifications.
  • Identify gaps, communicate any observations noted and review responses so that a positive working relationship with suppliers and service providers is maintained.
  • Write and review Technical and Quality Agreements to ensure robust systems are in place with suppliers and service providers.
  • Review and complete self-assessment and quality audit questionnaires from customers and Third-Parties.
  • Perform internal audits and provide feedback to the Quality Audit Manager on the GxP compliance of systems and processes.
  • Identify gaps and facilitate improvements to systems and processes to ensure adherence to current regulatory and GMP guidelines. Ensure that audit findings and actions are addressed in a timely manner.
  • Assist in the planning and execution of internal audit programs.
  • Assist in the planning, organisation and execution of customer and regulatory inspections.
  • Assess and review Quality records, for example CAPA’s, Out of Specification investigations, controlled changes, and audit actions. Facilitate their progress to resolution in a timely manner through communication with assignees and Quality personnel.
  • Undertake special projects which have arisen through communication with the Head of Supplier and Customer Quality Assurance and the Quality Director.
  • Write, review, endorse and authorise, as appropriate, SOPs, reports and Risk Assessments relating to the key duties and responsibilities of the job role and any relevant projects.
  • Participate in meetings and working groups as the Quality representative relating to the key duties and responsibilities of the job role and any relevant projects.
  • Deputise for the Head of Supplier and Customer Quality Assurance in meetings and take responsibility and accountability where appropriate.
  • To maintain knowledge of appropriate scientific and technical developments and advise Senior Management of relevant trends.
  • Provide support in an advisory capacity across the organisation with respect to specialist skills, expertise and knowledge.
  • To ensure the integrity, confidentiality and safety of data and intellectual property of a patentable and proprietary nature.
  • Ensure concerns regarding product safety and quality are drawn to the attention of colleagues and appropriate staff, including Quality and Senior Management
  • Plan, execute and complete supplier and service provider audits, including the preparation of audit reports, review of responses and audit closure.
  • Plan and organise the timely review and approval of Quality and Technical Agreement
  • Plan, execute and complete internal GxP audits, including the preparation of audit reports and progression of audit actions where appropriate.
  • Review the completion of Quality records, for example CAPA’s, Out of Specification investigations, controlled change tasks, and audit actions. Facilitate their progress to resolution in a timely manner.
  • Liaising with suppliers and service providers with regard to the scheduling, completion, review and closure of external audits.
  • Liaising with external organisations with regard to the completion and return of self-assessment and audit questionnaires.
  • Liaising with suppliers, service providers and external organisations with regard to the completion and approval of Technical and Quality Agreements.
  • Liaising with staff at all levels across site to facilitate the progression and completion of Quality records, for example CAPA’s, Out of Specification investigations, controlled change tasks, and audit actions.
  • Liaising with external organisations and regulators (e.g. MHRA and FDA) with regard to information requests.
  • Planning, co-ordination and execution of supplier and service provider audits.
  • Facilitating the completion and approval of Technical and Quality Agreements.
  • Facilitating the completion of customer and third-party audit and self-assessment questionnaires.
  • Planning, co-ordination and execution of internal GxP audit programs.
  • Ensuring that the Quality Department remains in compliance with regulatory requirements.

Skills and experience:

  • A scientific degree and/or a minimum of five years relevant pharmaceutical experience, ideally within a GMP environment.
  • A good knowledge and understanding of EU GMP and US CFR regulations and guidelines.
  • A good working knowledge of the EU and US Pharmacopoeias.
  • Qualification and/or experience in leading audits to GxP and ISO9001 standards.
  • Experience in planning and taking part in regulatory inspections.
  • An understanding of current GxP issues affecting (sterile) pharmaceutical manufacturing…… click apply for full job details

    Employment Type Permanent

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