Qualified Person & Regulatory Compliance Manager |£70000 - £71000 per annum
Pharma & Science
Permanent
South East

QP & Regulatory Compliance Manager

Additional Information

Location: Oxfordshire

Salary: Competitive + Bonus + Benefits

Hours: Full Time

Job Type: Permanent

Main Accountabilities

  • Senior Leader for the Quality Function
  • Fulfil legal requirement as MIA Holder and adhere to the guidance contained in Eudralex volume 4, Annex 16
  • Maintain eligibility to be named as a QP on the required DSC MIA; this includes maintaining knowledge of the company Life Science QMS
  • Review batch documentation, perform QP batch certification in accordance with the current Code of Practice, and deliver other QP related activities on behalf of clients;
  • Facilitate updates and maintenance of all authorisations in conjunction with Quality Administrator and Quality Team (GMP) and include any training around authorisations
  • Review and agree Quality/Technical Agreements in conjunction with Quality Management with Clients and Suppliers, and ensure full compliance is achieved against these agreements
  • Support the Quality Director with the delivery of the Quality and Regulatory Agendas at site/business level, ensuring harmonisation of best (GMP/GDP/ISO) practices is rolled out across all UKI Life Sciences sites
  • Support the Commercial & Packing Services Business by performing structured QP tasks ensuring that client specifications are followed, and the business is compliant with approved procedures, GxP expectations and MHRA guidelines
  • Support the delivery of the Quality Strategy for CTL, PS and Commercial Pharmaceutical on an annual basis as well as ensuring contractual KPIs are monitored, reviewed and achieved on a monthly basis, as appropriate
  • Support business growth by participating on client project implementations from a Quality and Regulatory perspective
  • Build and maintain excellent working relationship with our clients, peer groups, as well as with relevant regulatory and professional bodies
  • Attend and present as required Quality and Regulatory compliance status at management and business reviews both internally and with clients
  • Facilitate regular reviews with Quality Leadership Team and Responsible Persons
  • Liaise with QA/QC and client Quality teams in relation to investigation and resolving “deviations” which may occur during manufacture or within DSC’s chain of custody
  • Attendance at Regulatory Inspections as required
  • Undertake internal and external audits as requested and support hosting external audits where required
  • Contribute to content creation and the delivery of GMDP training
  • Maintenance of SOP training status for QPs
  • Facilitate regular training and awareness activities with QA and rest of the business around topical regulatory matters and/or processes e.g. validation, licences, serialisation, annex 16, IMPs
  • Raise Quality and Compliance awareness across operational and non-operational teams and functions in line with GMDP, ISO 9001 and ISO 13485 requirements

Experience and Qualifications

Functional

  • At least 5 years experience as a QP in areas stipulated by respective authorisations
  • At least 5 years Line Management experience
  • Market and industry knowledge in particular around GxP regulatory requirements and GxP compliance QMS and associated procedures.
  • Ability to advise clients on how to navigate through the CT process
  • 5 years+ experience in Pharmaceutical Manufacturing and Logistics
  • Experience in Medical Devices, Cold Chain, Validation, Transportation and Packaging preferred

Education And Qualification

  • Degree level education (Science degree)
  • At least 5 years experience as a Qualified QP in areas stipulated by the respective authorisations
  • Eligibility for nomination of a Qualified Person (Commercial and investigational medicinal products)
  • Logical, excellent attention to detail, methodical and good communication and organisational skills
  • Demonstrable Continuous Professional Development

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