Interim Lead Qualified Person Pharmaceutical

Interim Lead Qualified Person Pharmaceutical

Locations commutable to site: Bathgate  Scotland

Duration: 6 Month Contract

Working hours- Monday- Friday – typically 8am-5pm

Pay rate up to

£60-£80 inside IR35

Remote working opportunities available but you must be able to get to site at least 2-3 times a week if the business requires you on site.

Profile:

As the Lead Qualified person on the site you will have three direct report and the 14 indirect reports from those departments. You will also have experience of working with oral solid dosing or steriles experience

The responsibility of the role is to provide support to both the site business unit (BU) operations, as well as to the corporate Quality function. Manage and develop the team, including performance reviews and assessments

You will have a proven track record of working with in the pharmaceutical industry and have been the Lead Qualified  person or  Qualified person  and have been performing the routine and legal duties of a QP in compliance with the general principals of a QP as outlined in the Code of Professional Conduct. Work to EU directives 2003/82/EC and 2003/83/EC a Directive 2003/94/EC (human) or Directive 91/412/EEC (veterinary).

The role

• To provide leadership to the Qualified Person team, providing guidance and direction on the priorities for release, resolution of technical and compliance issues.  Acting as a QP within the group, in balance with line leadership duties.

• To act as key point of contact for Operational, Customer Services and Development personnel with regard to the release of batches, providing regular updates on release status. Ensure release of product to meet CRD schedule.

• Membership, in conjunction with other Qualified Persons, of Development and Technical Project teams providing guidance on GMP, regulatory compliance and Quality matters.

Manage and develop the QP team, including performance reviews and assessments

Technical Competency

1.   To perform the routine and legal duties of a QP in compliance with the general principals of a QP as outlined in the Code of Professional Conduct. To confirm semi-finished batches as a Qualified Person under EU directives 2003/82/EC and 2003/83/EC and comply with all the applicable GMPs, National Legislation and Requirements of the relevant Quality Agreement.

2.   Confirm the batch has been manufactured in accordance to the relevant GMP guidelines as stated in Directive 2003/94/EC (human) or Directive 91/412/EEC (veterinary).

3.   To ensure that all the products are manufactured in accordance with the registered particulars and the requirements of GMP, and that any deviations from procedures are documented and suitable action is taken in accordance with the appropriate SOPs.

4.   To ensure that abnormal events occurring during production/manufacture and testing are documented and suitable corrective or preventative action is taken.

5.   To ensure there is a process whereby Validation of the principal manufacturing and testing processes are complete and relevant.

6.   Ensure that the necessary quality control checks and tests in line with manufacturing procedure have been undertaken.  Retain reference samples of each product at the site of manufacture for the required period of time as specified by the EU regulations are maintained.

7.   To ensure any deviations in packaging, quality procedure or manufacture are notified in accordance with the defined reporting system and investigated before any product is released.  In addition ensure that any additional sampling and inspection, tests and checks are completed in response to these deviations.

8.   To provide technical support to the team of QA officers and other key contacts including but not limited to production and quality personnel.

9.   To represent the Quality group on new product introduction project teams.

10. To assist in the drafting and approval of master batch manufacturing records.

11. To review and approve SOPs, validation protocols, change requests, annual Product Quality Reviews and Planned Process Variations (PPVs) in accordance with company procedures and guidelines.

12. To review the requirements of Technical Agreements as required.

13. To perform audits (internal and external) as a member of the audit team and specifically the certification that API suppliers meet the requirements of the cGMPs for the manufacture of the API.

14. To assist in customer/regulator liaison, demonstrating our quality systems as required, and taking an active role when customer/regulators audit our site.

15. To support other Catalent businesses as may be reasonably required.

16. To support investigations, root cause analysis and facilitation of other problem solving or risk ranking tools as required.

17. The QP must ensure through relevant systems that regular audits, spot checks and self-inspections are completed; all legal requirements are met.  To ensure that any tasks that the QP has allocated/delegated to existing staff are being performed to the required GMP and EU standards.

18. The QP must sign in a register or other formal record that the product has been released by a Qualified Person.

19. To perform any other reasonable duties as may be required by line management.

20. To make the final batch disposition decision documenting any formal associated appropriate risk based decisions when releasing, re-working or rejecting products.

The Person:

This role requires a strong people manager who can drive change through the team. The candidate must have a pharmaceutical background.