Qualified Person - Bavaria
Responsibilities
- To maintain a robust quality system that fits the complexities of Company’s supply chain
- Perform certification of batches that are imported from outside the European Union in line with Directive 2001/83/EC
- Maintain QP certification register for all imported batches from outside the European Union
- To ensure that the company meets the requirements of Falsified Medicines Directive and the Delegated Regulation
- To ensure goods that have been delivered by bona fide suppliers are to a high standard
- To ensure goods that are damaged are returned to the supplier or destroyed by the appropriate contracted company following the company’s returns and or destruction procedures
- To check that goods supplied damaged by the client to clients are destroyed responsibly by client before issuing a credit note as described in procedures
- For cold chain products ensure goods have been maintained at +2°C to +8°C by checking temperature traces
- Be completely familiar with the client’s stock control system Orderwise and ensure goods are booked in accurately
- Ensure that the conditions of the site licenses are met, and the guidelines of Good Manufacturing Practice and Good Distribution Practice are complied with
- Check that Warehouse and Cold Room temperatures are kept between the parameters on a daily basis (Cold Room +2°C to +8°C and ambient Warehouse +15°C to +25°C)
- Ensure that Standard Operating Procedures (SOPs) are followed at all times
- Responsible for introducing new SOPs as and when required to support a new process or system
- Liaise with the German Health Authority where required
- Host German health authority inspections and client audits of the facility
- Check that the warehouse temperature probes are serviced and calibrated annually and records kept
- To train all employees and workers ensuring that they are fully competent in GMP/GDP requirements and all relevant SOPs
- Manage GxP related changes via the company’s change control process
- Manage deviations and CAPA processes via the company’s procedures
- Handle customer complaints in a timely manner and liaise with clients accordingly
- Ensure that the activities of the company are properly reflected in the relevant authorisations
- Ensure that the provisions of the site licences are met at all times
- Ensure that the operations do not compromise product quality and patient safety
- Ensure that adequate records are maintained in compliance with the retention periods
- Ensure that all personnel are trained to carry out their respective duties
- Ensure full and prompt cooperation with marketing authorisation holders in the event of recalls
- Oversee audit of the quality system and to carry out sufficient number of self-inspections as per defined programme
- Responsible for supplier and customer qualification prior to sourcing or supplying
- Performing on-site audit of suppliers as part of the supplier qualification process
- Carryout appropriate levels of validation and qualification of equipment and computer systems when required
- Prepare, maintain and deliver key performance indicators (KPIs) for all aspects of the quality system
- To identify and correct all trends developing via KPI monitoring
- Organise and host quarterly quality management review (QMR) meetings
- Liaise with clients to discuss their upcoming clinical trials and provide advice and guidance as to what documentation will be required to QP release their supplies once they have been packaged and labelled
- Hold weekly or biweekly calls with clients to ensure that the timelines for their clinical trials are on track from a QP release perspective
- Review and ensure that labels for IMP are compliant with Annex 13
- Provide QP declarations for material to be used in clinical trials where necessary
- In compliance with Annex 16, certify each batch of IMP for use in human clinical trials
Job Requirements
- Eligible to act as a QP in accordance with EU Directive 2001/83/EC
- Educated to a degree level within a life science subject
- Understanding of Directive 2001/83/EC as amended, of the Community Code relating to medicinal products for human use
- Knowledge of EudraLex, The Rules Governing Medicinal Products in the European Union, Volume 4 Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use
- Good Understanding of the EU GMP and GDP Regulations
- Good understanding of the German Pharmaceutical Licence obligations
- Understanding of, The New Guidelines for Good Distribution Practice of medicinal products for
Competencies
- Attention to detail and thoroughness
- Concern for standards
- Good planning and time management skills
- Excellent written and communication skills
- Self aware
- Flexible and adaptable
- Tenacious
Work Conditions
- Reports directly to the General Manager
- From time to time overtime may be required to meet project deadlines
- Ability to work under own initiative and as part of a team