Sector: Life Sciences
Consultant: Michele Dawson
Salary: £30000 - £40000
Job Status: Permanent / Full Time
Job Title: Responsible Person
Location: London NW2
Hours : Monday – Friday 9am – 5pm but flexibility will be required on occasion
Remuneration: £30-40K dependent on experience
The company was established in the early 2000s and now distribute over 20,000 products and they are also a leading manufacturer of over 700+ of their own brand label medical supplies lines.
Reporting to the Head of QA-QC and the COO the role is to ensure that all systems and processes are in place between suppliers and the company, within the company and from the company to customers and competent authorities are effective and compliant with GDP (EU GDP 2013/C 343/01) and the company QMS operates in line EU GDP/MHRA guidelines
You will have a professional background and previous experience (minimum 2–3 years) as an RP in the medical/Pharmaceutical industry with key accountabilities to self-manage all requirement of an RP.
- Ensure compliance with the general conditions of relevant Wholesale Distribution Authorisation, EU GDP Guidelines 2013/C 343/01 and relevant MHRA Guidelines, legal requirements and updates.
- Ensure compliance with the requirements of GDP guidelines both EU and MHRA.
- To carry out the relevant GDP SOP’s as instructed by the RP of the Company.
- Ensure the Quality System is implemented and maintained.
- Ensure that the conditions of the Wholesale Distribution Authorisation are met and that all medicinal products handled, are received, stored, transported and delivered under strict GDP conditions.
- Bona Fides
- Supplier/customer approval by ensuring initial Bona Fides are established and maintained annually, for all relevant suppliers and customers in advance of product receipt or supply and sign off by the RP.
- The RP will ensure copies of all wholesale/manufacturing authorisations are in place, valid and maintained in the English language.
- Ensure that only the relevant product classes procured from approved suppliers and supplied to approved customers are covered under own Wholesale Distribution Authorisation.
- Retain all GxP records for at least 5 years.
- Document all procedures
- Ensure that all staff handling medicinal products are trained in GDP and the specific SOPs so they can operate competently in the GDP duties assigned to them. All training must be properly recorded and reviewed by RP. GDP training must be both initial and ongoing.
- Ensure that the Premises and equipment are suitable for the handling of medicinal products, including transportation and supply chain activities.
- Review and sign off temperature records on a monthly basis and handle all temperature excursions. Ensure timely notification to the relevant party for all relevant product temperature excursions/status.
- Review and if acceptable approve all returned product to saleable stock.
- Be involved in any decisions to quarantine or dispose of returned, rejected, recalled or falsified/suspected falsified medicines.
- Be the decision maker on all relevant non-conformances and corrective, preventative actions and complaint management/customer service.
- Identify areas where improvements can be made in processes which could lead to improved quality.
- Consult regularly with relevant persons especially Management on all GxP related topics/issues and updates including Risk Management.
- Ensure Management meetings which take place and are minuted to ensure a regular review of operations, quality and supply chain issues and key performance indicators.
- Ensure self-inspections and audits are carried out as per the written audit schedule.
- Ensure the facility operates to all standards listed in GxP as per products stored on-site.
- Manage all recalls in conjunction with the staff and also schedule mock recall(s) at least annually, if required. Personally, close out all product recalls.
- Act as the main point of contact and be legally responsible to the MHRA and advise MHRA of any changes to facilities or changes to RP in a timely fashion.
- Update personal training and attend at appropriate regulatory workshops/training courses, to keep up to date as regulations and standards change and improve.
- Focus on the management of authorised activities and the accuracy and quality of records.
- Ensure that all relevant customer complaints are dealt with efficiently and effectively.
- Approve any/all relevant subcontracted activities.
- Maintain appropriate records of all relevant delegated duties.
- Ensure that any additional requirements imposed on certain products by National Law are strictly adhered to (Article 83 of Directive 2001/83/EC)
- Knowledge and experience of applying pharmaceutical regulations relating to GDP
- Knowledge and experience of Quality Management Systems, including ISO9001.
- Knowledge of Controlled Drugs regulations.
- Knowledge of COSHH and Hazardous Transportation regulations.
- Understanding of the management of storage and transportation of temperature-sensitive pharmaceuticals.
- Understanding of Standard Operating Procedures and Quality Management Systems
- Understanding and experience of auditing
- Pharmaceutical qualification
If this is of interest, please click the apply now button. For more information, please contact Harvey in the Life Sciences team.