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Qualified Person, Pharmaceuticals

Job Title: Qualified Person, Pharmaceuticals
Contract Type: Permanent
Location: London, England
Industry:
Salary: Negotiable
Reference: J905695_1594308448
Contact Name: Tom Hammond
Contact Email: tom.hammond@russell-taylor.co.uk
Job Published: July 09, 2020 16:27

Job Description

Qualified Person, Pharmaceuticals

Location: Greater London

Type: Permamant

Salary: CIRCA £90,000

Our Client, an established Pharmaceutical company are looking to recruit a permanent QP onsite at their modern facility in Greater London.

PRIMARY RESPONSIBILITIES

  • Batch certification as per Directive 2001/83/EC

SECONDARY RESPONSIBILITIES

  • Responsible for the review and approval of Standard Operating Procedures, review and approval of study protocols
  • Responsible for CMO management and compliance
  • Responsible for being part of internal and external auditing as Lead auditor for GMP, GCP, GDP and GLP purposes;
  • Managing Quality Assurance and Working cross functionally with Quality Control Departments for the involvement and overview required to the role in all the Quality System related tasks, with proactive participation in problem solving in case of GMP, GCP and GLP issues.
  • Provide input into the Regulatory strategy for the development of pharmaceutical products in the UK
  • Liaising with the Regulatory Authority/MHRA contact for all pharma products sold in UK
  • Working cross functionally with Pharmacovigilance, Regulatory Affairs, Clinical Research
  • Managed in all aspects of the sterile production including design, installation, operational and performance qualifications and process validation.
  • Plan, execute and supervise the standard training program for all new employees and maintain continuous training for all staff
  • Develop training courses as a separate business unit within the department
  • Maintain all professional knowledge databases
  • Ad hoc projects
  • Any other duties as and when required

ESSENTIAL EXPERIENCE

Eligible to be named as a Qualified Person (MUST BE A QUALIFIED QP)

  • Preferable Experience in the licensed manufacture of the following:

Oral solid dosage

Oral liquid dosage

  • Practical experience of auditing for GMP, GCP, GDP and GLP purposes
  • Experience of Quality Management Systems

Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our Privacy Policy h t t p s : / / w w w . r u s s e l l - t a y l o r . c o . u k / p r i v a c y - p o l i c y on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or the GDPR please contact us on h r @ r u s s e l l - t a y l o r . c o . u k

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