Location: Watford (Wembley, Barnet, Harrow)
Start date: ASAP
The Qualified Person position sits within the European quality department including UK, whose primary accountability is to ensure that all Quality related GxP activities are compliant, in addition to providing quality assurance expertise.
The role of the Qualified Person is required to act in compliance with the legal responsibilities and routine duties as defined by EU Directives and Local Law with regards to dispositioning of batches for the UK and supporting with QP related activities.
-To act as a Qualified Person in accordance with EU/UK GMP to provide final certification/batch dispositioning to the UK market in good co-operation with the BMS testing and disposition co-ordinator to assure timely dispositioning.
- To review and approve relevant quality documents under which: change control request, technical agreements, analytical method transfers, NCRs, PQRs, SCs, APQRs, risk assessments, data-logger statements, in-licensed master batch records from partners / manufacturing sites in compliance with marketing authorisations.
-To review and provide support and final assessment of OOX investigations and contract laboratories
-To provide QP GMP declarations in support of importation activities on Marketing Authorisations.
-Support the EU QMS group to ensure a state of compliance for Europe
-To function as lead auditor for internal and external audits
-Function as supervisor of the QP support officer
-Function as lead host for MHRA inspections and customer audits
-Handle specific issues as: (potential) recalls for products
-Act as hierarchical supervisor of the QP support officer
KNOWLEDGE, SKILLS AND ABILITIES
Education (degree / diploma)
• Scientific degree (pharmacy, microbiology, chemistry) eligible to act as UK Qualified person (2001/83/EC)
• Previous experience as a QP for OSD (Oral Solid Dosage Form) and OLD (Oral Liquid Dose Form) and SSD (Semi Solid Dosage form), and Inhalers
• Wide experience of a Quality role in a pharmaceutical company
• Auditing experience –GMP/ICHQ7A/ISO9000/PS9000
• Experience, knowledge, judgment and confidence to make decisions when faced with ambiguity
• Must be able to operate calmly and effectively under the typical pressures of such a role
Knowledge and Skills (Functional / Technical)
• Analytical thinking, able to see cause and issues and clearly identify solutions and way forward
• Knowledge of pharmaceutical development process
• Ability to interpret the regulatory requirements in a pragmatic manner to support the business
Leadership / Managerial Attributes
• Excellent written and verbal communicator
• Ability to immediately establish a professional working relationship with auditors and auditees, both internal and external
• Integrity, explaining good reasons for decisions and actions
• Excellent team-working and managerial skills
• Influential and persuasive in achieving objectives
• Thorough with an excellent eye for detail and good organizational skills
Other requirements (licenses, certifications, specialized training)
• Membership of appropriate professional society, e.g. Royal Society of Chemistry, Society of Biology, Royal Pharmaceutical Society of Great Britain.
If you are interested, or know anyone who is, then don't hesitate to apply or email directly at firstname.lastname@example.org