Sector: Life Sciences
Consultant: Life Sciences Team
Salary: £37000 - £40000
Job Status: Permanent / Full Time
Job Title: Responsible Person
Location: NW London
Salary: Up to £40k depending on experience
Role purpose is to work with and report to the Licence Holder and Senior Management to ensure Good Distribution Practice (GDP) Compliance of Pharmaceutical Products, be responsible for the management of the Quality Management System, and to be involved with advising the Senior team of legislative guidelines that could impact the running of the Business. Be responsible for ensuring a product or service meets the established standards of quality including reliability, usability and performance.
Main Tasks and Responsibilities:
- Responsible for QA oversight of all GDP activities in all markets in accordance with local requirements; ensure product procurement, storage and distributions are managed in accordance with GDP requirements.
- Assess cold chain and ambient product shipments and provide corresponding quality decision on product quality and patient safety.
- Provide guidance and monitor Quality issues related to cold chain, ambient products and GDP to resolution within the company and with external parties.
- Raise and Review documentation including change controls, deviations, CAPAs, validation documentation, SOPs and specifications relating to distribution activities.
- Management of the Quality Management Systems.
- Maintain, review and updating of Standard Operating Procedures for Quality Assurance and Distribution related activities ensuring compliance with GDP regulations.
- Ensure Quality Agreements are in place for all outsourced activities.
- Provide Quality support and oversight for Distribution Operation review meetings with Distribution contractors.
- Contribute to defining standard quality KPIs for all companies and to review quality indicators with recommendation for actions for improvement in relation to GDP contractors.
- Prepare of inspections from regulatory bodies such as the MHRA and the Home Office and provide support for regulatory submissions. Coordinate and support on-site audits conducted by external providers
- Evaluate audit findings and implement appropriate corrective actions
- Ensure the conditions of all Wholesale Distribution Authorisations are maintained.
- Ensure that the operations do not compromise the quality of medicines by ensuring that appropriate systems are in place to monitor the procurement, storage and distribution of the Pharmaceutical products through the supply chain under the control of the company.
- Reviewing and advising upon the company’s standard operating procedures in relation to the operation of the licence.
- Ensure that all records generated in relation to GDP are accurate and legible and maintained in a secure manner.
- Ensure any subcontracted activities which may impact on GDP are approved and that suppliers (audit if required) and customers are approved and to maintain an approved customer and supplier list.
- Ensure that customer complaints are processed efficiently and effectively.
- Coordinate and perform any recall operations with the support of the purchasing manager and Sales Team
- Keep up to date with any Thefts of Medicines and Falsified Medicines
- Develop, recommend and monitor corrective and preventive actions
- Coordinate and ensure that all complaints are dealt with effectively (investigation,- documentation; communication)
- Investigate non-conformance issues and coordinate Deviations.
- Approve the qualification of the Pharmaceutical Customers & Suppliers and ensuring Khaos & Orderwise computer systems are updated accordingly.
- Keeping accurate and up-to-date record as such the documents are legible, traceable and retainable.
- Perform and monitor risk management Quality Risk Management activities
- Plan and conduct self-inspections
- Interpret and implement quality assurance standards
- Review the implementation and efficiency of quality and inspection systems
- Perform Self-inspections and prepare reports to communicate outcomes of quality activities
- Check training records and identify training needs and organise initial and ongoing refresher training interventions to meet quality standards.
- Assure ongoing compliance with quality and industry regulatory requirements
- Report annual returns of Controlled Drugs to the Home Office
- Sign off all supplier and customer Bona Fides.
- Final sign off on Returns disposition
- Final sign off on Recall reports.
- Deal with temperature excursions of shipments and internal warehouse and ensure mapping protocol in place
Education and Experience:
- Bachelor’s degree preferred
- Quality inspection, auditing experience
- Experience with implementation of corrective action programs
- Product or industry-specific experience
- Strong computer skills including Microsoft Office, QA applications and databases
- Knowledge of tools, concepts and methodologies of QA
- Knowledge of regulatory requirements regarding awarding organisation recognition and Quality Assurance
- On-site Parking
- Responsible Person Pharma : 1 year (Required)
If this is of interes please click apply now. For more information, please get in touch with Harvey in the Life Sciences team.