Department: Operations
Reports to: Head of Operations
______________________________________
MAIN PURPOSE OF ROLE:

The role is to provide clear management and leadership within the primary packaging facility. You will continually strive to achieve consistent and efficient production output whilst maintaining exceptionally high quality levels. The post holder must be a seasoned production manager having experience with primary packaging within a GMP controlled environment.

KEY RESPONSIBILITIES:
• Plan production schedules and generate production plans to meet customer demand.
• Use, as the master tool, the company’s ERP system to issue works orders and to manage raw material stock levels.
• Liaise with customers, building relationships to ensure we meet their requirements.
• Maximize yield and improve process efficiency through teamwork, problem solving and continual improvement.
• Produce, maintain, review, evaluate and sign-off production documentation and ensure compliance with GMP requirements and internal standards.
• Manage and co-ordinate the activities of all personnel within the pharmaceutical primary packaging department.
• Ensure that staff training and development is fulfilled, and monitor staff progress through maintenance of training records and regular appraisals.
• Coach personnel where weaknesses occur.
• Be actively involved in identifying machinery and process improvements and optimising usage to maximise output.
• Introduce/assist with new business requirements and projects, systems, equipment, etc as required (e.g. serialisation).
• Maintain knowledge of GMPs and associated regulatory considerations in a commercial pharmaceutical packaging environment.
• Assist other stakeholders with qualification and validation activities associated with the build/ upgrade of new/existing Production facilities and the install/upgrade of new/existing processing equipment, in line with relevant GMP, Quality and Engineering standards.
• Investigate operational problems affecting production, product quality and process quality and subsequently recommend and deliver solutions.
• Actively work within the Pharmaceutical Quality System managing corrective actions, deviations and change controls.
• Ensure the work area and machinery is safe to use and free from hazards.
• Keep the Head of Operations informed of breakdown and downtime KPIs.
• Communicate widely with internal and external stakeholders/business partners where required.
• Manage and prioritise the active and variable workload to ensure efficient execution of the production plan.
• Complete all works to high standards of quality whilst working within GMP guidelines.
• Maintain and use GMP documentation for all aspects of the job as expected within a pharmaceutical environment.
• Ensure Health & Safety objectives are met.
• Play a key mentoring role in the development of new personnel to assist their learning and develop the next line of talented GMP personnel for the company’s growth plans.
• Provide cover for the production manager responsible for secondary packaging.
• Any other ad-hoc duties that maybe required by your Management Team.

PERFORMANCE STANDARDS:
1. Experience within pharmaceutical production.
2. Experience of PQS – (Pharmaceutical Quality Systems). CAPA, Change Control, Deviation.
3. Must possess a sound understanding of Microsoft Office software.
4. To fully utilise the IT systems and to plan production activities.
5. Experience in GMP documentation
6. To maintain professional standards and adhere to the company’s policies and procedures at all times
7. To be able to work under pressure
8. To be punctual, maintain dress standards, be polite and courteous to internal and external customers at all times.
9. Willing to remain adaptable and flexible.

QUALIFICATIONS:
Previous experience as a production manager within a pharmaceutical production environment

EXPERIENCE & COMPETENCIES
Experience within primary packaging of solid dose products
Experience with Commissioning, Validation and Qualification of buildings and equipment.
Experience in managing personnel with a wide range of skills

KNOWLEDGE & SKILLS
Excellent communication, both written and oral English.
Excellent working knowledge of Microsoft Office software suites
Excellent planning and time management skills
Good people liaison skills
Ability to manage multiple tasks as well as being able to set priorities in order to address as they arise

PERSONAL QUALITIES
• Pro-active and self-motivated with well organised and logical approach to work
• Positive attitude and flexible approach to work•
• Reliable and punctual•

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