Quality Compliance Manager / Responsible Person
Reports to: The Directors, Diamond Compliance & Quality Limited
Based at: Suite 2, Ground Floor, Field House, Station Approach, Harlow, Essex CM20 2FB
Job purpose: Diamond Compliance & Quality Limited is a consultancy company dedicated to providing high quality and competitively priced services in the area of manufacturing compliance to the biotech and pharmaceutical industries. The role will be to run the day‐to‐day activities associated with all GxP consulting tasks required by pharmaceutical clients and to ensure Diamond Compliance & Quality has the necessary quality systems and processes in place in order to meet all Quality and Regulatory GxP standards.
Key responsibilities and accountabilities:
- To set up and maintain a quality management system in compliance with current GxP requirements.
- To provide clients with support for all aspects of GxP compliance for example auditing, validation, training.
- Advising clients on all aspects of GxP.
- Auditing – API, finished dose form, QC laboratories and storage and distribution warehouses.
- Provide training/education as necessary to both in‐house staff on aspects associated with GxP.
- To provide support for clients undergoing Regulatory Inspections.
- To ensure Diamond Compliance & Quality Limited obtains and maintains the necessary manufacturing and wholesale dealer licences of clients to support their business needs.
- To maintain an awareness of current legislation associated with GxP.
- To ensure Diamond Compliance & Quality Limited is available for Regulatory Inspection(s).
- General advice on development aspects.
- Ability to act as a Responsible Person on clients Wholesale Dealer Authorisations.
- To participate in conjunction with the Marketing Authorisation Holder and/ or Wholesale Dealer with any batch recall.
- To ensure that the necessary Agreements are in place to define the responsibilities of both parties in relation to Responsibilities of the RP.
The role will involve some travel worldwide.
The following attributes and skills are a guide:
- A life science background, with a degree
- Experience of working in the pharmaceutical industry or regulatory authority inspections division
- Around 5‐10 years’ experience
- May already be an independent consultant
- May have worked in all facets of the industry ranging from R&D; Production; Quality Control; Regulatory and Quality Assurance.
- Must have the experience to work across a range of dose forms (oral, topical, inhaled, injectable); biological experience would be an advantage
- Experience in auditing manufacturing, warehousing sites and supply chains a must
- Good computer skills
- Act as a Responsible Person for companies relating to their Wholesale Dealers Licence(s).
- Trained/certified auditor.
- Capable of actively seeking and bringing in new business
- Ability to work on their own or as part of a team
- Excellent communication skills
- Well organized and good planning abilities
- Team‐based work ethic
- Good eye for detail