Jd - Quality Manager

QUALITY MANAGER Manage the team of quality assurance and control personnel to ensure that the facility operates according to the Quality Management System and our products are made to the required quality standards for sterile products, fully compliant to regulatory requirements, right first time. Accountabilities/Responsibilities

1. Quality. Ensure that medicinal products are manufactured fit for their intended use, complying with the requirements of the Marketing Authorisation and do not place patients at risk due to inadequate quality. Ensure there is a comprehensively designed and correctly implemented system of Quality Assurance Incorporating Good Manufacturing Practice, and Quality Control and Quality Risk Management., fully documented, its effectiveness monitored and adequately resourced with competent personnel, with suitable and sufficient premises and equipment. •

to approve or reject starting materials, packaging materials, and intermediate, bulk and finished products

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to evaluate batch records

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to ensure that all necessary testing is carried out; to approve specifications, sampling instructions, test methods and other Quality Control procedures

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to approve and monitor contract analysts

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to verify the maintenance of department, premises and equipment

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to ensure that the appropriate validations are done

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to ensure that the required initial and continuing training of department personnel is carried out and adapted according to need

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the authorisation of written procedures and other documents, including amendments

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the monitoring and control of the manufacturing environment

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plant hygiene

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process validation

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training

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the approval and monitoring of suppliers of materials

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the approval and monitoring of contract manufacturers

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the designation and monitoring of storage conditions for materials and products

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perform internal and external audits programs to ensure compliance to GMP

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to front inspections

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Monitor changes within the regulatory environment with a view to reporting status of the quality systems to the management team and implement new quality initiatives and strategies

2. Customer Service. Ensure that the quality department is capable of and reliably and repeatedly demonstrates that it delivers on time.

3. Cost. Manage and control departmental expenditure within agreed budgets demonstrating continual improvement in cost control without compromise to quality, safety or customer service.

4. Safety. Ensure that Quality is a safe place to work. 5. TOPIC. Manage the Quality Control Laboratory to achieve the performance objectives Customer Service, Quality, Cost and Safety, ensuring that there are the necessary resources in terms of manpower (both in quality and quantity), systems, technology, information, materials and equipment to meet the business objectives. Maintain appropriate systems for measuring performance and demonstrate continual improvement.

6. People Management. Manage, direct, motivate and develop all staff, ensuring the recruitment, management, training and motivation of staff according to company procedures, policy and employment law. The job holder must have the following Skills Essential Desirable Appraisal Assertiveness Coaching Consultancy Counselling Customer Care Financial Management Interviewing Managing Meetings Negotiating Persuading & Influencing Presentation Problem Solving Project Management Report Writing Selling Strategic Planning Time Management Training

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The job holder must have the following Behaviours Essential Desirable Action Orientated Active Listening Adaptability Controlling Creativity Data Facility Decisiveness Delegation Detail Handling Establishing Direction Helicopter Vision Influencing Initiative Interpersonal Sensitivity Judgement Need to Achieve Planning & Organising Spoken Communication Stress Tolerance

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Vision

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Team Working Tenacity Willingness to Learn Work Standards Written Communication

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