Production Manager

2 weeks ago


Port Elizabeth, South Africa Fresenius Kabi Full time

The Production Manager holds a pivotal leadership position, ensuring that all manufacturing activities comply with rigorous regulatory, quality, and safety standards. This role is responsible for overseeing the entire production process to
The duties of Production Manager are defined according to SA GMP Guide.
? Ensure the timely supply of quality product to our customers
? Ensure that production relevant documentation is GMP compliant, on-time and
reviewed prior to approval
? Ensure that products are produced and stored according to the appropriate
documentation in order to obtain the required quality
? Implement/support risk-based approaches for all manufacturing aspects,
operations and equipment within the department
? Oversee the development, implementation of and the adherence to the
Standard Operating Procedures (SOP’s) in the department
? Ensure the areas of the department meet hygiene and cleanliness standards
i.e. ensure that cleaning is appropriate and efficient according to production
needs
? Ensure appropriate validation for equipment and processes are performed in
the area of responsibility
? Ensure that adequate maintenance is carried out on all equipment, utilities and
the manufacturing areas
? Support QA in all department-relevant quality investigations, for example
product recalls, complaint investigation, deviations, OOS and change controls
? Ensure that there is a system in operation within the department to facilitate
the inspection, investigation and taking of samples in order to monitor factors
which may affect product quality
? Represent the department during inspections and audits
Budget & Cost Control
? Develop and control the financial budget for the department
? Control and optimize the cost within the department
? Set quality and performance KPI’s for the department and monitor the
departmental performance on a defined frequency
? Continuously improve processes to introduce World Class Manufacturing
practices within the business
? Develop strategic roadmap for the department to meet market and business
requirements for the present and future conditions
? Identify opportunities for productivity and efficiency improvements. Included
in this will be the improvement of product yield.
VACANCY
People Management
? Manage all personnel in the department and provide ongoing performance
feedback to staff as and when required
? Ensure that all personnel in the department is developed and trained as
required by the various job functions
? Ensure best working practices within the department
? Set quality and performance KPI’s for the department and monitor the
departmental performance on a defined frequency
Quality Management
? Oversee the development, implementation of and the adherence to the
Quality Management System for the department
? Ensure compliance to all QM controlled processes and documents
? Represent the department during inspections and audit
Performance Measurement
? According to Plant and Production KPI defined through the annual performance
management process
maintain cost efficiency and minimize downtime, while spearheading continuous improvement initiatives aimed at reducing waste and boosting productivity.
Scientific degree; preferably B. Pharm/BSc. Micro/ BSc Operations
Management/ BSc Industrial Engineering
? If the incumbent is not a pharmacist, then the subordinates (department
managers) should be Pharmacists registered with SAPC.
? Skills Matrix “Production Manager” role for local SOP’s
? At least 10 years production experience as production manager on Senior
Management Level
? Strong management experience
? Strong manufacturing process understanding
? Experience in continuous improvement techniques
? Can-do attitude
? Pharmaceutical Industry experience
Specific Aspects
? Ensure compliance with all relevant cGxP and Quality standards/procedures in
your area
? Responsible to ensure that subordinates are appropriately trained in
accordance with training matrix
? All Personnel have the responsibility to comply with the OHS Act (ACT 85 OF


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