Department: Quality, Technical and Compliance
Reports to: Waymade and/or Atnahs Head of Quality

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MAIN PURPOSE OF ROLE
Responsible for batch certification of licensed products (therefore must be eligible to be added to an MIA under the permanent provisions of Directive 2001/83/EC for Medicinal Products for Human Use).
Responsible for ensuring that all medicinal products are manufactured to the requirements of EU GMP.
Facilitate / Support investigations from procedures/instructions and/or abnormal events are investigated and documented and suitable corrective/preventative actions are taken.

    Must confirm before each product batch certification
  • Marketing Authorisation requirements have been met including all product testing in line with current specifications and batch records satisfactory
  • EU GMP complied with, including:
  • Supply Chain risk map available and up to date
    Each batch documentation completed and authorised
    Self-Inspection programme appropriate and up to date
    Other relevant factors satisfactory i.e. transport conditions
    Sampling within EU or within 3RD Country is satisfactory
    Deviations and OOS Incidents satisfactorily investigated to root cause and documented with appropriate CAPA
    Safety features required in line with Delegated Regulation (EU) No 2016/161 have been affixed to each pack
    EU GMP Annex 16 has been complied with

    KEY RESPONSIBILITIES
    Provide primary QP release function in line with EU directives for the Certification of Medicinal Products
    Provide secondary cover for the RP release function in line with EU directives
    Evaluate Site Master Files, drug master files and regulatory dossiers received from third parties, as needed. Recommend appropriate actions needed to ensure expeditious submission and approval
    Provide GMP subject matter expertise directly and indirectly to the Company and its partners
    Lead investigations, root cause analysis and facilitation of other problem solving or risk ranking tools as required
    Ensure that manufacturing, assembly and testing and release operations are carried out as required to procedure and as stipulated in relevant Marketing Authorisation submissions
    Support the Quality review and approval of SOPs, master GMP related documentation, batch manufacturing records, validation protocols, analytical specifications, change requests, quality reviews, planned changes in accordance with procedure
    Review and Approve Technical Agreements
    Maintain up to date knowledge of regulatory requirements, including GMP/GLP, and advise colleagues, business partners & management of implications of current and new requirements
    Support the Company’s representative at any Regulatory Inspections undertaken by the relevant competent Authorities
    Support Review of batch records for New Product Developments
    Actively support site improvement projects i.e. conversion from paper PQS to electronic
    Other duties as assigned

    QUALIFICATIONS
    Eligible to be added to an MIA under the permanent provisions of Directive 2001/83/EC for Medicinal Products for Human Use
    Degree in Chemistry, Biology or Pharmaceutical Science
    Postgraduate Degree in Pharmaceutical Studies or equivalent
    Registered as member of either: Royal Pharmaceutical Society, Royal Society of Chemistry or Royal Society of Biology
    API Auditing and or GMP Auditing certification

    EXPERIENCE & COMPETENCES
    Experience working within a Pharmaceutical Company as a Qualified Person releasing Solid Dose products
    Proven experience of supporting manufacture and packaging of solid dosage forms, liquids, creams and sterile products
    Proven experience of supporting MHRA Inspections
    Previous experience within Quality Assurance, creating policies and procedures, internal auditing, reviewing deviations, change control requests, CAPA etc.

    KNOWLEDGE & SKILLS
    Excellent working knowledge of Current EU Guide to GMP and ability to apply this knowledge
    Excellent communication skills both written and oral with the ability to forge good working relationships with internal and external customers
    Good working knowledge of Risk Management
    Excellent time management skills

    PERSONAL QUALITIES
    Enthusiastic and highly motivated
    Positive attitude and flexible approach to work
    Calm, systematic, logical thinker
    Mental strength to stay focused reviewing several documents

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