Quality Manager

Job Description

Quality Management, QMS management and implementation. Team leader of QA/QC department, based in North england, with a competitive salary and benefits package.Client DetailsThe client is a rapidly expanding pharmaceutical company based in the North of England, they are looking for an experienced Quality manager to enhance and build their Quality team and QMS.DescriptionPrimary Responsibilities

• To lead and manage the operational performance of the Quality Department (both QA and QC functions) ensuring the successful delivery of business strategy, KPIs 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
• Final product release for products manufactured on site
• Responsible for internal QA audits
• Ensure integration/ alignment of quality systems within group QA/RA
• To support all Validation and Qualification activities at the site.

• Establishment and start of a Quality Department
• Hiring and manage people for the new 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 companys 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 (client, internal, external)
• To instigate and manage projects to ensure the business continues to operate to cGMP.

ProfileOther skills or attributes

• Excellent communication skills with people at all levels.
• Hands on mentality
• Significant experience in a technical background.
• A thorough knowledge of cGMP and other regulatory requirements.
• Demonstrated resourcefulness, innovation and initiative.
• 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:

• Scientific degree (ideally pharmacy, pharmaceutical sciences, biology, chemistry or related).
• Experience of coordinating and participating in regulatory inspections.
• Previous experience in the Pharmaceutical industry.
• Excellent project management skills.
• Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
• Excellent verbal and written skills with the ability to communicate at all levels.
• Computer literate in Microsoft Office (i.e. word, excel, outlook, PowerPoint).

Job OfferThe client is a rapidly expanding pharmaceutical company, offering a very competitive salary and benefits package with the freedom of improving the QMS onsite.

Keyskills :
Quality AssuranceQuality ControlQualityQMSISO9001Quality Manager