Responsible Person (RP), Pharmaceutical Location: Widnes (covering other Liverpool sites too) Type: Permanent Our client.
Read on to fully understand what this job requires in terms of skills and experience If you are a good match, make an application.
a global pharmaceutical company whose brands are easily recognized is looking to recruit for an RP/ Responsible Person The Role: Overall quality requirements for different dosage forms (product presentations), reasons why certain storage conditions are required, and risks associated with any temperature excursions occurring during storage and/or transportation.
The RP must be able to demonstrate up to date knowledge of GDP requirements, and how these are embedded within the systems and processes implemented at the wholesale distributor.
Some key areas of knowledge and experience are listed: Knowledge
- Storage conditions/requirements for different types of pharmaceutical products in their facility.
Basic understanding of degradation pathways and typical stability profiles of pharmaceutical products;
- GDP legislation and relevant guidance; (including any national requirements)
- Requirements for storage facilities, temperature control and monitoring programmes, including mapping and qualification;
- Quality Management Systems (QMS) and how to manage these effectively;
- Understanding of current data integrity expectations
- Handling of returns/complaints/recalls;
- Bona Fide checks;
- Risks associated with Falsified Medicines;
- Expectations of a robust Technical (Quality) Agreement with contractors & outsourcing companies;
- Narcotics and psychotropic substances, plus other controlled medicines legislation;
- Auditing requirements and auditing techniques.
Experience of picking /packing procedures and FEFO (First Expiry, First Out) principles;
- Managing quality complaints and customer queries including service issues;
- Active involvement in GDP regulatory inspections;
- Sufficient familiarity with the GDP operations of the Licence Holder
- Personally involved in internal audits to monitor the QMS and look for weaknesses then opportunities to improve.
Also involved in customer audits of the site plus external audits covering the various stages in the distribution process;
- Supplier and Customer approval process;
- Creating/maintaining/auditing the documentation and records involved to ensure compliance with GDP
- Sufficient understanding of typical IT systems used in GDP activities.
- Security of storage, traceability during storage and onward distribution.
The Person: Will hold an upto date RP qualification Will have worked in a similar GMP/GDP setting with a good understanding of CAPA, OOs, OOt, change controls etc.
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