W1siziisimnvbxbpbgvkx3rozw1lx2fzc2v0cy9tb3jzb24vanbnl2jhbm5lci1kzwzhdwx0ltmuanbnil1d

Home

Quality Manager

  • Location

    Fareham, Hampshire

  • Sector:

    Manufacturing

  • Job type:

    Permanent

  • Salary:

    £40000.00 - £45000.00 per annum

  • Contact:

    Neil Clark

  • Contact email:

    Neil.Clark@morson.com

  • Job ref:

    142422NC3_1524559724

  • Published:

    4 months ago

  • Expiry date:

    2018-05-24

  • Start date:

    ASAP

Quality Manager

To develop, establish and maintain quality assurance systems to ensure compliance with current legislation GMP/GDP, GCP and MDD

To act as Responsible Person for the sites named on the Wholesale Dealers Licenses in accordance with EC legislation and Qualified Person in accordance with the Code of practice for Qualified Persons

To maintain systems for supplier quality management

RESPONSIBILITIES:

To maintain the Wholesale Dealers License, Wholesale Dealers Import License, Home Office License, Home Office Import and Export Licenses

To develop, implement and maintain SOP's in order to meet the requirements of current legislation, Serono GMP Quality Standards, the guides to cGMP/cGDP, GCP and MDD

To co-ordinate all GMP activities, in accordance with relevant SOP's including:

  • QC inspection of unlicensed medicines and devices
  • Complaint handling
  • Returns management
  • Documentation management
  • Change control management
  • Deviation handling
  • Audit management
  • Documentation management
  • Specifications management
  • Validation management
  • Supplier quality management
  • Monitoring and review management
  • Quality requirements for IMP
  • Receipt, storage and distribution management
  • Quality management by Personnel Facility, utilities and equipment management
  • To co-ordinate the response to customer complaints and review/report complaints on a regular basis and make recommendations

To manage product recalls, including reporting to regulatory authorities

To set up a GMP audit programme for both internal audits and for contractors, carry out audits and write audit reports

To provide GMP training to contract personnel as required and keep records. To monitor GMP compliance and proved a regular written account on quality performance

To participate in the development of and co-ordinate changes to product packaging to ensure compliance with legislative, marketing and production requirements

To establish and maintain safety information sheets in accordance with COSHH regulations and coordinate all relevant activities

To establish and maintain effective working relationships with manufacturing sites, Corporate personnel, MHRA, IMB, Home Office, distributors and contractors, as appropriate, to ensure GMP compliance

To liaise with other registered Qualified Persons and Authorised Signatories for devices

To maintain an up-to-date knowledge of technical status of products and licences and provide input

regarding the prioritisation of the need to update licensed details.

To maintain an-to-date knowledge of current EU/UK legislation and industry standards pertaining to

pharmaceutical products and devices

To co-ordinate local activities related to compliance with Medical Device Directive including providing input to the development of devices and kit