Qualified Person

5 months ago

Luton, United Kingdom Target Healthcare Limited Full time

The **Target Healthcare Group** is a niche pharmaceutical developer, manufacturer and supplier to the retail pharmacy, hospital, pharmaceutical wholesaler, and homecare markets.

Within the Group, **Target Healthcare** is the UK's leading manufacturer and supplier of unlicensed medicines and hard-to-source products. We offer an unrivalled product range, backed by expert knowledge and exceptional customer service. Throughout the UK the Group employs close to 500 including pharmacists, skilled technicians, HR, IT, procurement, warehouse, and customer services staff.

Our Quality Assurance department are key to making sure the products we make and distribute are of the highest standard and that all our departments are working in compliance with Good Manufacturing Practices. We are looking to add a Responsible Person to the team.

As Qualified Person, your role/responsibitilies will include (but not limited to):

- Following, promoting, and enforcing relevant SOPs, Job Aids, and Company policy and procedure.
- Acting as a Qualified Person for the certification of licensed medicinal products and over-labelling in accordance with Annex 16.
- Proactively supporting the businesses operations and providing regulatory guidance.
- Ensuring that each finished medicinal product batch has been manufactured in accordance with GMP, the terms of the MIA (Manufacturing Authorisation), and the MA (Marketing Authorisations).
- Ensuring that certification is recorded in a register or equivalent document.
- Assuring that the QMS for the Manufacturing License is appropriate and maintained.
- Involvement in GMP Health Authority Inspections; QP input for readiness, preparation and coordination, follow-up, and commitments implementation.
- Supporting Product Complaints related investigation as necessary.
- Supporting recall investigations

**As with all Group employees, you'll also be asked to**:

- Ensure the work you do is of a high standard and that Group procedures and policies are followed.
- Act as an ambassador for the business, presenting the Group in a positive way with clients, customers, and colleagues.
- Work flexibly and efficiently to meet customer needs, whilst maintaining the highest possible professional standards.
- Always maintain confidentiality and security.

**To be successful in this role, you should be able to demonstrate**:

- Experience of operating as a Qualified Person named on a license.
- Demonstrable experience of working autonomously and making decisions.
- Strong, up to date knowledge of Good Manufacturing Practices.
- Confident dealing with managers and employees at all levels.
- Experience working in pharmaceutical / healthcare / life sciences industry.
- Highly computer literate; experience operating with all Microsoft Office software.

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