Qualified Person

3 weeks ago


Middlesex, United Kingdom Chemilines Group Full time

Role: Qualified Person (QP)

Type: Full time or Part time

Reporting to: QA/QC Manager and Resident Qualified Person (QP)

Purpose: The role is involved in all aspects of the Quality Management System within the company and to act as one of the named Qualified Persons on the Manufacturing Licences.

Location: Chemilines Ltd., Chemilines House, Alperton Lane, Wembley, Middlesex, HA0 1DX

**Main responsibilities**
- Perform the duties and responsibilities of a ‘Qualified Person’ as detailed under the provisions of EU Directive 2001/83/EC (Human Medicines) and 2003/94/EC (cGMP).
- Ensure that Marketing Authorisation (Assembly Only) requirements have been met for all batches of medicinal products, prior to certifying and ‘release for sale’ of these batches to the market.
- Ensure that principles and guidelines of cGMP (Directive 2003/94/EC) as interpreted in the EU Guide to cGMP and cGDP (The Orange Guide), have been followed.
- Manage the development of the Quality Management System covering all activities with the Group in line with the evolving regulatory requirements and changes and ensuring appropriate reporting to Management.
- Co-ordinate with appropriate Regulatory Bodies and ensure inspection requirements are fully satisfied.
- Assist with specific Group projects and undertake QP / QA responsibilities with regards to requirements under MDD 93/42/EEC and ISO 13485 and OBL (Own Brand Labelling).
- Undertake regular internal inspections on an ad-hoc basis across the site to ensure standards are being maintained. Suggest improvements/non-compliance and propose corrective actions on consultation.
- Ensure effective maintenance of granted licences including variations and renewals.
- Oversee all aspects of trade mark notifications including preparation of samples and maintaining up to date knowledge of legal requirements, including assessing the applicability of the “Specific Mechanism” to potential products.

About us

Chemilines Group is a successful importer, wholesaler and distributor of pharmaceuticals, generics and branded fragrances. We are also manufacturers of surgical dressings and medical devices. With a growing customer base and increasing product portfolio the Company is now set for further expansion. Providing excellent customer service support and production facilities, the company is dedicated to its customers who include leading retail and national pharmacy groups & wholesalers. We are located in Wembley, West London. The nearest Tube stations include, Alperton, Hanger Lane and Perivale (Piccadilly & Central Lines).

What we offer
- A friendly and supportive work environment.
- Free car parking on site.
- Staff discount on fragrances.

**Job Types**: Full-time, Part-time, Permanent

**Salary**: £80,000.00-£100,000.00 per year

**Benefits**:

- Company events
- Company pension
- Free parking
- Sick pay

Schedule:

- Monday to Friday

Work Location: One location



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