Qualtiy Assurance Manager (RP Status)
Leading Business that is still growing
Long Term Development Opportunities
About Our Client
This company are part of a market leading group supplying specialist products into a versatile customer base. As the Qualtiy Assurance Manager (RP Status)you will play a big part in ensuring efficient and consistent processes to meet customer needs. You will be leading the site and supporting the wider business in maintaining compliance to GDP and GMP.
As the Qualtiy Assurance Manager (RP Status) you will be instrumental in maintaining and advancing the company's quality improvement strategy. You will be working closely with the senior management contingent to form a best practice working culture.
Key Responsibilities include:
- To support the business in maintaining the QMS system compliance to ISO 9001 & GDP/GMP.
- To continuously Improve our QMS and associated processes and documentation
- Approve the initial and continuous training programme for all personnel involved in storage distribution activities
- Deliver compliance training in accordance with company standards as directed by line manager.
- Overseeing the management of deviations and CAPAs and reporting on deviation metrics.
- Approve and review CAPA Forms issued in accordance with the CAPA process
- Complete a regular non-conformance (or CAPA) trend analysis and to present those results as part of the management review meeting
- Scheduling and managing the supplier audit program and performing supplier audits.
- Scheduling and managing the internal audit / self-inspection program and performing internal audits.
- Participate in customer meetings as directed by line manager
- Participate and coordinate customer audits and manage and communicate any subsequent corrective actions
- Provide compliance input into new business propositions and implementations
- Execute route/lane risk assessments and analysis on behalf of customers
- Performing process mapping and improvement activities.
- Scheduling, managing and performing internal ISO audit / self-inspections and business continuity exercises.
- Ensuring that all QA department activity is performed in accordance with defined procedures and customer instructions and where applicable appropriate records are maintained.
- Provide risk management and risk mitigation support in respect existing customers as required by customer support staff
- Ensuring that quality incidents, client / customer complaints and deviations are appropriately recorded, investigated, corrective actions identified and communicated.
- Training and mentoring site Quality teams
- Acting as Responsible Person in line with GMP/GDP ensuring all licences and authorisations are maintained
- Named as Responsible Person on the licences and undertake those responsibilities in line with the regulatory requirements and the documented procedures
- Will ensure the technical requirements, such as temperature mapping process, temperature monitoring, premises and equipment validation are correctly implemented, recorded and approved
The Successful Applicant
A Quality Assurance Manager Responsible Person with experience in the pharmaceutical industry, working to GDP or GMP standards.
The successful applicant will have:
- Experience in a quality assurance function within the pharmaceutical industry or pharmaceutical distribution industry and the associated supply chain needs
- Successfully completed an MHRA accredited RP course
- Must be or have been previously named as a Responsible Person on a licence
- An excellent working knowledge of the principals and guidelines of Good Distribution Practice/GxP and the associated legislation
- Understanding of QSHE processes, requirements and formats and compliance to ISO9001
- Experience in writing clear and concise policies and procedures
- Ability to conduct and design training events / training experience
What's on Offer
Circa £45,000 - £50,000 + Car + Benefits