Job URL
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Job Details
Job ID: 132
Job Title: Quality Control Manager (Maternity Cover)
Job Type:
Hire Type: Direct Hire
Level: Experienced - Non Managerial
Recruiters: Hannah Woodward,Sophie Taylor
City: Hengoed
Country Wales

Job Description
Description: Reporting to; Quality Control Director
Location; Hengoed
Tenure; Fixed Term/Secondment (9 months)

To effectively manage the activities of the Quality Control Section to ensure the achievement of compliance standards and meet business and customer expectations.
Requirements/Qualifications: • A relevant scientific degree is essential and a higher degree is desirable
• Experience at a senior level in Pharmaceutical Quality management and a thorough knowledge of GMP/FDA guidelines for the manufacture and testing of pharmaceutical products
• Analytically strong with highly developed knowledge and ability to specify and use IT systems to achieve process improvements and the conversion of data into meaningful business information
• Wide operating knowledge of analytical skills and an understanding of validation techniques.
• Excellent knowledge of Quality Management systems.
• Project management and project leadership experience, well developed planning skills with ability to meet deadlines
• Previous experience in managing, developing staff. Demonstrated track record of staff management
• Excellent verbal and written communication skills in English, , including the ability to communicate persuasively
• Ability to present effectively to groups
• Influencing and negotiating skills
• A team player
• Excellent networker with the ability to collaborate and agree outcomes
• Current driving licence is required
• Ability to challenge the status quo and develop efficient systems
Responsibilities: • Ensure purchased materials and manufactured drug products are tested using registered methods and specifications which supports the effective management of the Supply Chain by efficient control of the Quality Control section.
• Through the use of extensive experience, credibility and leadership skills manage the Quality Control team, strategies and customer relations.
• Ensure compliance of all laboratory systems and equipment with laboratory GMP
• Maintain a stability programme supporting the local manufacture of drug products
• Membership of Site Quality Council and Site Leadership Team
• Supporting the Site Director of Quality in working with the Medical, Commercial Business Units and R&D to support global quality processes.
• Globally support projects and initiatives and to act generally on behalf of all Norgine legal entities including without limitation, inspections/audits etc.
• Support the business requirements for investigative work, method validation, technology transfer and method enhancement as appropriate, or supply of any other information as appropriate.
• Creation and control of QC budget
• Identification and implementation of projects to improve efficiencies and maximise resources

RELATIONSHIPS:

• Excellent teamwork within and across M&S and all other Business Units, plus external representation with key agencies/authorities.
• Close collaboration with key Norgine personnel across all Business Units and within M&S
• Ability to work and lead successfully in a matrix organisation.
• Leadership and line management of staff
• Ability to influence and challenge
• External relationships, in particular Regulatory Authorities and other Industry professionals

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