Quality Compliance Group Leader

Location
Craigavon
Salary
Dependent on experience
Posted
18 Apr 2019
Closes
16 May 2019
Ref
J5631353
Contact
Eve Hegarty
Contract Type
Permanent
Hours
Full Time
Eve Hegarty at Hyper Recruitment Solutions is currently working with global pharmaceutical company in their search for a Quality Compliance Group Leader, to be based at their facility in Country Armagh.

As the Quality Compliance Group Leader you will be responsible for leading the Quality Compliance Team to ensure the efficient and effective day to day management of the Pharmaceutical Quality System (PQS) on Site. This position will primarily be focused on Quality Systems, Quality Compliance and providing QA support to business projects to ensure compliance with the principles of GMP and Pharma Services PQS.

Key words: Quality Compliance | Quality Systems | Quality Management Systems | Group Leader | Team Leader | Pharmaceuticals | GMP Manufacturing

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Quality Compliance Group Leader will be varied however the key duties and responsibilities are as follows:

1. Lead and develop the Team Leaders to provide high level quality governance of the Pharmaceutical Quality System. Take responsibility for performance management, staff development and oversee the training needs of the team. Become a primary point of contact for the business, providing technical advice/guidance on the PQS Systems and quality compliance standards including regulatory expectations.

2. Periodically review quality systems and practices to identify efficiencies and to assure greater compliance. Lead improvement initiatives identified to ensure full implementation of changes within the Business.

3. Manage and schedule the teams workload to ensure client and business needs are met and ensure that adequate resources are available within the Compliance Team to support routine quality operations and business growth whilst maintaining compliance. Manage and support the Team Leaders to oversee the individual PQS elements ensuring compliance with the procedural requirements, cGMP and regulatory expectations.

4. Provide a Quality review and authorisation of a range of quality documentation including SOPs, Policies, Guidelines, Specifications.

5. Participate in the audit team and assist in the delivery of quality products / services etc from third parties. This will include audits of Drug Substance manufacturers, packaging suppliers, third party Drug Product manufacturers, service providers etc.

6. Participate in the preparation, hosting and completion of responses to Customer Audits and Regulatory Inspections. Provide technical assistance during such audits as required.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Quality Compliance Group Leader we are looking to identify the following on your profile and past history:

1. Relevant BSc, MSc or PhD in a life sciences or engineering related discipline.

2. Significant practical experience of GMP manufacturing and/or packaging processes, including experience working within an established Pharmaceutical Quality System. Experience of all quality system aspects including: deviations, CAPA, complaint handling, auditing, change management, analysis, KPIs' and Risk Management. Ideally you will be a qualified lead auditor and have experience hosting or supporting regulatory inspections.

3. This is a leadership role, therefore you must be able to demonstrate significant line management experience as well as experience dealing with customers in a scientific capacity.

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.

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