Quality Manager

Culina; St Helens; On-site; GBP 60,000 - 90,000; Full time

Benefits offered by this job

Annual leave 25 days

Private medical cover

Pension scheme

Life assurance

Wellness – EAP

Eye care vouchers

Rewards and recognition

Discount platform

Job summary

Culina IPS is seeking a Quality Manager to lead the Compliance and H&S functions and ensure GDP compliance across the site. You will act as the Named RP on WDA(H) and the Controlled Drug licence, and drive the Quality Management System aligned with MHRA GDP guidelines.

You will manage audits, CAPA/NCR processes, change control, and vendor/ subcontractor oversight while developing training and reporting to support continuous improvement and regulatory readiness.

Qualifications

• Minimum 3–5 years as RP in medical/pharmaceutical industry.
• Experience applying GDP guidelines and HSE practices.
• Strong attention to detail and communication skills.
• Able to manage audits and CAPA processes.
• Proactive in training and change management.

Responsibilities

• Act as Named RP on WDA(H) and Controlled Drug licence.
• Maintain and improve Quality Management System per GDP guidelines.
• Generate and approve GDP documents.
• Create annual audit programme and perform RP audits.
• Approve subcontracted GDP activities.
• Lead MHRA, client and corporate audits.
• Create and review Technical Agreements.
• Manage CAPA and NCR investigations and resolutions.
• Review validation protocols and ensure system validation.
• Decide final disposition of returned/rejected products.
• Coordinate product recalls.
• Manage risk assessment programme and mitigation.
• Oversee change management and documentation controls.
• Oversee sampling and QA release of products.
• Oversee training programmes.
• Review temperature records and manage excursions.
• Host QM Review meetings and produce compliance reports.
• Manage team of 3 (RP, QA Specialists).

Skills

GDP compliance

HSE knowledge

Quality management

Leadership

Auditing

Documentation control

CAPA/NCR management

Communication

IT skills

Job description

As a Quality Manager 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) and all relevant legislations (COMAH, EU Medical Devices Directive 93 / 42 / EEC etc.)

• Named as the primary Responsible Person on the WDA(H) and Controlled Drug licence
• Maintain and continually improve the company's Quality Management System in compliance with current MHRA 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 audit programme, 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 NCR 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 QA Specialists)
  You will ideally have a professional background and previous experience (minimum 3-5 years) as an RP in the medical/pharmaceutical industry with key accountabilities to self-manage all requirement of an RP
• 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
  IPS (Part of the Culina Group) works with some of the best known brands and provides cost effective and innovative co-packing, co-filling and co-manufacturing solutions within the UK.
• 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!
• As part of our drive to make IPS a 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 normal bank holidays.
• Company Bonus - We do our best work to succeed together. When we achieve our goals you'll be rewarded through our bonus scheme
• Private Medical Cover - This gives you peace of mind, you have choice, flexibility and speed of access to the most clinically appropriate care via Bupa
• Pension scheme - we want colleagues to enjoy a comfortable retirement so we offer a great contribution of 4% employee and 4% employer
• Life Assurance - 4 x your annual salary
• Wellness - Via our Employee Assistance Programme we 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!