Head of Quality (GMP)

Are you experienced in a GMP environment with the ability to lead a QA/QC team?

Can you implement the required processes, standards and procedures to ensure a business acquires a GMP accreditation?

If so this role with a market leading business is just for you....

Primary Responsibilities

To lead and manage the operational performance of the Quality Department (both QA and QC functions) ensuring the successful delivery of business strategy, KPI's and objectives, whilst adhering to regulatory compliance and achieving commercial success

To be an active member of the site management team representing the quality function and participating in regular meetings and contributing to the overall efficient operation of the business.

Coordinating, overseeing and supporting the day–to–day running of the department and allocation of work.

Ensure activities within the department are in line with company policy, best practice and cGMP compliant

Provide guidance and support to other departments to ensure their compliance to company policy, best practice and cGMP

Produce results in line with company policy, best practice and cGMP in the desired timeframes as directed by the business and by their line manager

Facilitate review and approval of change control and deviation records.

Oversee Quality Assurance activities; document control; implementation of an EQMS system; Microbiology and Analytical functions.

Management of Drug Master Files in conjunction with Group requirements

Product release for products manufactured on site

Responsible for internal and external QA audits

Ensure integration/ alignment of quality systems within group QA

To support all Validation and Qualification activities at the site.

Experience in participating in/leading Health Authority inspections and readiness

Job Description:

Establishment and start of a cGMP Quality Management System

Hiring and day–to–day management of people for the department

The ability to consistently perform and understand the tasks that are the responsibility of the Quality Department.

Have consistency in the results generated and their routine performance to inspire trust and confidence from their line manager and other areas of the business in the work they are requested and expected to perform.

An excellent awareness of cGMP procedures and processes.

An understanding of how company's procedures relate in the larger regulatory environment and an ability to place them in context.

The ability to take a leading role within the team and support a team working culture.

Have excellent time management/organisational skills in order to perform their job efficiently; requires minimal input from line management in order to achieve planning/deadlines

Successfully liaise with members of other departments at all levels to resolve any Quality related issues creating a partnership working environment.

Perform cGMP and Quality related intra– and inter–departmental training.

Suggest innovative and practical ideas/solutions to problems.

Liaise with internal and external customers on Quality matters.

Support of group supply chain in terms of supplier qualifications – this may include some international travel

Lead and support audits/inspections (Health Authority, client, internal, external)

To instigate and manage projects to ensure the business continues to operate to cGMP.

Other skills or attributes

Significant experience in a technical background.

A thorough knowledge of cGMP and other regulatory requirements.

Demonstrated resourcefulness, innovation and initiation.

Ability to allocate and utilise resource to ensure completion of projects on time.

Ability to take responsibility for technical and other decisions in the running of the department.

Conflict management and resolution orientated skills.

Education and background:

Scientific degree (ideally pharmacy, pharmaceutical sciences, biology, chemistry or related).

Experience of coordinating and participating in regulatory inspections.

Previous experience in the Pharmaceutical industry.

For more information on this vacancy or to discuss your wider job search, please call Scott Webb directly on (phone number removed).

This vacancy is being advertised by Teespro Recruitment Ltd, our services are that of an Employment Agency & Business