Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world.
We are currently 1,100 people headquartered in the UK with global offices in the US, EU, JAPAC and South Africa. Clinigen has grown rapidly since our inception, we are the leader in Managed Access programs and positioned well for an exciting future of continued growth.
The Role:
We are seeking a customer focused, analytical and process driven Quality Assurance Manager/Responsible Person who will be part of our newly built European Distribution Centre in Dublin. You will be responsible for ensuring operations are carried out within the Quality team are completed in accordance with the requirement of the GxP regulations and guidelines, Clinigen Quality systems, and industry standards. You will lead one other Quality Specialist with a view to growing the team over the next 18 months.
As our newly appointed Responsible Person (RP) you will play a pivotal role in safeguarding product users by ensuring Good Distribution Practice (GDP) and minimising the risk of potential hazards in the supply chain. You will have a clear reporting line to the licence holder/MD with 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 Include:
- Primary host for client audits and responsible for the tracking and management of client audit actions
- Ensure the provisions of the wholesale distribution authorisation (WDA(H)) are observed
- Supporting and ensuring an adequate quality management system is established and maintained
- Supporting the management of authorised activities and the accuracy and quality of records
- Maintaining oversight that initial and continuous training programmes are implemented and maintained
- Co-ordinating and promptly performing any recall operations for medicinal products
- Maintaining oversight of the process to ensure that relevant customer complaints are dealt with effectively
- Maintaining oversight of the process to ensure that customers and suppliers are approved
- Approving any subcontracted activities which impact upon GDP for the European Distribution Centre.
- To oversee audit of the quality management system 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
- Keeping appropriate records of any delegated duties;
- Deciding 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:
- Misuse of Drugs Act 1977 as amended
- Misuse of Drugs Regulations 1988 and any other associated applicable regulations
- Compliance with EU Falsified Medicines Directive (Directive 2011/62/EU)
- 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 Relevant Regulatory Authority.
Requirements
- Pharmacy degree or minimum of one-year experience on a licensed wholesale dealing site
- Demonstrable experience of working within a quality assurance role, or other related role (essential)
The Responsible Person should have basic knowledge of:
- 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)
Additional Requirements Include:
- 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
Interested? We would love to hear from you, please apply today for consideration.
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