Clinigen is a rapidly growing global specialty pharmaceutical services business with a unique combination of services across the pharmaceutical lifecycle. We currently have over 1,000 employees headquartered in the UK with global offices in the US, EU (Belgium, Germany, France), Asia Pacific and South Africa. Clinigen is growing rapidly and is positioned well for an exciting future of continued expansion.
To support our growth, we are seeking a diligent, detail-oriented and experienced Responsible Person to form part of our highly skilled quality team reporting into the licence holder. In this key role you will be responsible for safeguarding product users by ensuring GDP and minimising the risk of potential hazards in the supply chain.
You will have access to all areas, sites, stores and records which relate to the licensable activities and regularly review and monitor all such areas to ensure the necessary standards are achieved. You will have the authority to make decisions to ensure GDP compliance can be demonstrated and that all regulatory obligations are met.
Key Responsibilities, Not Limited To:
- Primary host for client audits and responsible for the tracking and management of client audit actions
- To ensure that the provisions of the wholesale distribution authorisation (WDA(H)) are observed
- Ensure an adequate quality management system is established and maintained
- Support the management of authorised activities and the accuracy and quality of records
- Maintain oversight ensuring initial and continuous training programmes are implemented and maintained
- Co-ordinate and promptly perform any recall operations for medicinal products
- Maintain oversight of the process to ensure that relevant customer complaints are dealt with effectively
- Maintain oversight of and support the process of customers verification and supplier approval
- Review and approve any subcontracted activities which impact upon GDP for the Weybridge and Byfleet facilities.
- Oversee audit of the quality management system and participate in and ensure that self-inspections are performed at appropriate, regular intervals following a pre-arranged programme and that any necessary corrective measures are put in place
- Keep appropriate records of any delegated duties
- Decide on the final disposition of returned, rejected, recalled, damaged or falsified products
Responsible for ensuring that there is full compliance with the statutory requirements of:
- 1) Misuse of Drugs Act 1971
- 2) the Misuse of Drugs Regulations 2001 and any other associated applicable regulations
- 3) the conditions on any licence that may be issued, and that there will be in place written operating procedures that should be available on request by the Home Office.
Requirements
- Minimum of two years’ experience on a licensed wholesale dealing site
- Demonstrable experience of working within a quality assurance role, or other related role (essential)
- EU legislation (EudraLex)
- Directive 2001/83/EC (as amended) of the European Parliament and of the Council of 6 November 2001 on the Community code Relating to Medicinal Products for Human Use
- The Human Medicines Regulations 2012 as amended
- Current Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01)
- Demonstrable business and commercial awareness
- Effectively able to utilise a range of IT skills
- Able to handle multiple responsibilities, priorities and tasks
- Demonstrable reasoned logic to decision making and ability to recommend solutions in complex situations
- Adaptable to changing situations, with a proactive positive, flexible, assertive, can do attitude
- Good influencing and stakeholder management skills
- Strong written and verbal communication skills
- Able to influence and lead by example, clearly communicating plans and results, promoting ownership and encouraging a collaborative approach to achieve solutions
- Evidence of being able to build relationships with key internal and external customers
- Ability to work with tight deadlines in a dynamic environment, delivering high quality outputs with strong attention to detail
- Prioritisation and time management skills
- Pharmacy or other life science degree, preferable
Benefits
- 27 days holiday, plus bank holidays
- Discretionary Bonus
- Pension contributions & Life Assurance scheme
- Flexible Benefits Platform
- Annual salary review
- Independent financial advice service
- Enhanced Employee Assistance Programme
- Shopping discounts with retailers
- Long service awards
- Recognition scheme & employee of the year awards
Interested? We would love to hear from you, please apply today for consideration.
