UK - Quality Assurance Specialist - CELGJP00009070

  • Location

    Uxbridge, London

  • Sector:

    Healthcare

  • Job type:

    Contract

  • Salary:

    Negotiable

  • Contact:

    Abbas Anwar

  • Contact email:

    abbas.anwar@experis.co.uk

  • Job ref:

    BBBH118182_1580811343

  • Published:

    9 months ago

  • Duration:

    12 Months

  • Expiry date:

    2020-03-05

  • Start date:

    ASAP

  • Client:

    #

QUALITY ASSURANCE SPECIALIST - UXBRIDGE - £30/£34 PER HOUR - 12 Months

QUALITY ASSURANCE SPECIALIST - UXBRIDGE - £30/£34 PER HOUR - 12 Months

The work location is UXBRIDGE and is a 12-month contract.

Pay rate is between £30 - £34 per hour.

The role is working for a global biopharmaceutical company which employs more than 7,000 people located in more than 60 countries.

Competences

The Contract Senior Quality Assurance Specialist will report functionally to the Director, QA.

They will report administratively to the Senior Manager, QA.

The primary role of the Contract Senior Quality Assurance Specialist is to support and execute routine quality assurance tasks to ensure compliance with all GMP, regulatory and corporate requirements.

Products may be for investigational or commercial use.

Duties and Responsibilities

Responsibilities may include, but are not limited to, the following:

  • Manage contractor quality compliance activities to ensure product is manufactured, packaged, tested, released and distributed in compliance with all regulatory and corporate requirements.

This includes:

  • Building and maintaining good working relationships with the contractor
  • Leading discussions with the contractor on quality related topics, such as complaints, change control, deviations, OOS records, processes, methods, procedures, documentation, etc.
  • Recommending quality related improvements to the contractor
  • Overseeing completion of contractor quality related activities, such as process, method and procedural improvements, quality investigations, corrective and preventive actions, etc.
  • Review batch records, both master production/packaging records and executed batch records ensuring compliance with GMP and registration requirements.
  • Manage change control requests. This includes, as necessary:
  • Initiating and approval routing of change control requests
  • Performing QA evaluation and endorsement/approval
  • Review of associated contractor change control requests
  • Monitoring progress of related action items
  • Process product complaints. This includes, as necessary:
  • Recording complaint details
  • Contacting complainant for additional information and/or to request samples
  • Contacting CSP to coordinate manufacturing investigation
  • Finalising complaint investigation
  • Performing and monitoring trend analyses and reporting to upper management
  • Review, edit, negotiate improvements to, and approve CSP documentation, including:
  • Process validation protocols and reports
  • Transfer validation protocol and reports
  • Investigations, Deviations, OOS records
  • Author Product Quality Review reports, as necessary. Or, review, edit, negotiate improvements to contractor supplied Product Quality Review reports.
  • Draft or review, negotiate with contractors, and recommend approval for Quality Agreements
  • Participate in self-inspections as appropriate
  • Participate in external audits of contractor manufacturers and distributors as assigned
  • Ensure logs, databases and files related to the product quality activities are maintained
  • Performance of trend reviews and compilation of metrics

For non-product related duties:

  • Develop and/or maintain pharmaceutical quality systems, as assigned
  • Author and/or revise standard operating procedures and associated work instructions, as assigned
  • Review and provide recommendations on policies and standards, as assigned
  • Support GMP/GDP site inspections, as assigned
  • Maintain compliance with personal training requirements

Skills/Knowledge Required

  • BSc (or equivalent) in a technical or scientific discipline
  • Demonstrated pharmaceutical quality experience (equivalent to a minimum of 5 years' experience), including experience/knowledge of audit, batch record review, change control, complaint handling, investigations and SOP creation and update
  • Must have thorough knowledge of pharmaceutical manufacturing, packaging, testing, and distribution processes and associated global regulatory GMP/GDP requirements (US and EU, particularly)
  • Must have demonstrated understanding of the processes and interactions essential for ensuring and maintaining regulatory compliance
  • Must have strong task management skills with the ability to prioritize, schedule, and control multiple projects and resources simultaneously under tight deadlines
  • Must have excellent communication skills, including excellent written, interpersonal, collaboration, and negotiation skills, with a team-oriented approach
  • Must have exemplary problem solving and organizational skills
  • Must have computer proficiency
  • Must have attention to detail