MAIN PURPOSE OF ROLE:

  • Support other internal business units with completion of their PQS activities.
  • Support the training of staff to comply with company PQS.
  • Organising timely completion of product batch reviews in conjunction with Technical Manager.

    KEY RESPONSIBILITIES:

  • Support other internal business units with completion of their PQS activities.
  • Where applicable initiate the request for stakeholders to raise deviations and change controls in a timely manner.
  • Support compliance officers with the completion of batch reviews (both QP and RP) in conjunction with the batch priorities determined in the weekly batch release priorities meetings.
  • Support Compliance Officers if required in monitoring completion of Complaints, CAPA, Deviations and Change Controls.
  • Complete assigned PQRs given by the technical managers.
  • Support completion of internal audits.
  • Other duties as assigned.

    KEY ACCOUNTABILITIES

  • Evidence of timely completion PQS activities by internal business units.
  • Evidence of timely feedbacks and escalations to HOQ, QP, RP and Technical Managers.
  • Evidence of timely completion of assigned PQR.
  • Evidence of supporting Compliance Officers in batch reviews.

    PERFORMANCE STANDARDS: To maintain a professional standard always.

  • To be punctual, polite and courteous to Waymade Group customers and to all staff always.
  • To ensure compliance to all the Company’s Policy and Procedures i.e. Health and Safety, GXPs, SOP and Dress code, etc.

    Qualifications:
    A Level in 3 Science subjects
    Graduate in Pharmaceutical Science or equivalent
    Postgraduate Degree or Diploma in Pharmaceutical Science or equivalent

    Experience & Competences
    Proven experience of solid dosage forms, liquids, creams and sterile products
    Previous experience creating of updating policies and procedures
    Previous experience of working in a Quality Department of a Good Manufacturing Practice environment/ pharmaceutical company in a role with increasing responsibility.
    Previous experience of working in pharmaceutical Quality / production / packaging departments.
    Previous experience of working in an international regulatory environment.

    Knowledge & Skills
    Good working knowledge of Current Good Manufacturing Practice, Standard Operating Procedures, MHRA guidelines and ICH Guidelines
    Working knowledge of change control procedures
    Excellent communication skills both written and oral and proficiency in Microsoft packages.
    Knowledge of use of Electronic Quality Management Systems.

    Personal Qualities
    Positive attitude and flexible approach to work•

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