Quality Manager and Responsible Person

Company Description

Great Bear (Part of the Culina Group) provides distribution services to FMCG clients. Customer centric service focus is delivered through a site-level empowered culture.

At Culina we have a winning culture, we believe that our culture is one of the reasons our company continues to thrive A place where you're valued, challenged, and inspired!

Job Description

As Site Quality Manager and Responsible Person you will be responsible for managing the Compliance and H&S department and ensuring the overall GDP compliance of the site.

You will have a key responsibility in maintaining and developing all aspects of compliance management and Health & Safety profile of the site. Carry out all duties in such a way as to ensure that the wholesale distributor can demonstrate compliance with EU Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013 / C 343 / 01), Human Medicines Regulations 2012 (C17) and all relevant legislations (COMAH, EU Medical Devices Directive 93 / 42 / EEC etc.)

Working hours : Monday to Friday, 40 hour week.

Key Duties of a Quality Manager :

Named as the primary Responsible Person on the WDA(H) and Controlled Drug licence for site.

Maintain and continually improve the companys Quality Management System in compliance with current GDP guidelines, applicable certifications and group policies and procedures.

Responsible for the generation, revision, approval of procedures and other GDP documents

Responsible for creation of annual self-inspection schedule, performance of RP audits and management of self-inspections.

Ensure that any subcontracted activities which may impact on GDP are approved

Act as the lead contact for MHRA, client and corporate audits

Responsible for creation and review of Technical Agreements

CAPA and deviation management. Responsible for management of the investigation and resolution of operational discrepancies and customer complaints having final approval of outcome.

Review and approve validation protocols and ensure that all systems are validated

Decide on the final disposition of returned, rejected or falsified products

Coordinate and promptly perform any product recall operations

Management of risk assessment programme and ensure that the mitigation strategies are defined and implemented

Responsible for change management. Ensure that change control process in place for documentation, processes and systems

Oversee sampling and quality assurance release of products

Ensure that initial and continuous training programmes are implemented and maintained

Review and sign off temperature records and handle all temperature excursions. Ensure timely notification to the relevant party for all relevant product temperature excursions

Host Quality Management Review meetings, collate monthly Quality stats and produce compliance reports.

Manage team of 3 (Compliance and H&S Manager and 2 Quality Coordinators)

Qualifications

You will ideally have a professional background and previous experience as an RP in the medical / pharmaceutical industry with key accountabilities to self-manage all requirements of an RP

Hold Cogent Gold Standard Training Certification for Responsible Persons

Quality Manager experience

Knowledge and experience of applying GDP guidelines and H&S

Experience in examining and reengineering procedures and developing and implementing new strategies and procedures

Effective time management

Strong attention to detail

Strong interpersonal and communication skills

Confidence and assertiveness

Excellent IT skills (including Microsoft Office packages)

Dynamic and self-motivated, keen to achieve excellence within the business

Additional Information

As part of our drive to make Great Beara great place to work. We are proud to be an inclusive and diverse organisation where we are committed to employee development and recognising success for hard working performers.

Our dedicated learning and development programmes are open to every employee to give you the opportunity to shape your own future within logistics and continue to work in an environment where team culture thrives.

Our People are the driving force behind our success, which is why we offer a wide range of benefits which include :

Annual Leave

Competitive holiday entitlement of 25 days plus the bank holidays.

Pension scheme

we want colleagues to enjoy a comfortable retirements so we offer agreat contribution of 5% employee and 8% employer.

Life Assurance - x 4your annual salary.

Wellness

Via our Employee Assistance Programmewe offer immediate access to a confidential telephone counselling and legal information service that operates 24 hours a days, 365 days a year.

Eye Care Vouchers

We can provide you with substantial savings with free eye tests and discounts on prescription glasses.

Reward & Recognition

We recognise that employees have gone the extra mile via Employee of the month and year, special recognition and long service awards.

Everyday discounts - via our benefit platform you will have access to over 50 retailer discounts for everyday savings!

If you meet the requirements for the above role and are looking for your next career opportunity please apply now and become a part of our #WinningTeam!

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