Job Description:
Production Manager
Purpose:

A well-known pharmaceutical organization urgently is seeking a Production Manager to join their organization who will be responsible for ensuring the effective functioning of the designated filling department with regard to manufacturing quality product in accordance with all relevant specifications and SOP within good manufacturing practice housekeeping and safety standards

Key Job Outputs:

General Outputs

Organizational Effectiveness and Resource Management: Resource Planning/ Monitors Good IR Climate/ Competence and Awareness Training
Monitor Compliance with the requirement of GMP in the manufacturing environment
Comply to relevant sections of the OSH Act and SHE (Safety, Health and Environmental) requirements
Comply to the requirement of the organisation’s quality management System (SABS ISO 9001:2000 / 20-08-17-004)
Control of the organisation’s Document Management System is applied
Production Controls
Control of non-conforming product handled per relevant department SOP’s / Specifications
Continues Improvement
Ensure Execution of EE Plans
Resource Allocation

Review the production programme to determine the resources (man, machine and material) required for meeting the required volume and efficiencies
Draws up daily allocation list and ensures that Operators assigned to the Printing, Filling, tipping, pouching, sealing and truck loading operators are competent and trained in the tasks that they are assigned to operate
Ensure that the production lines are balanced
Ensure that the material handlers order and deliver the material required for production timeously and in FIFO
Decides on the best way to allocate the resources in order to achieve the required volumes and efficiencies
Decides on actions to be taken in the event that production lines are not balanced
Monitor Performance

By utilising the short interval control report (SIC report) monitors the actual units achieved against the targets on an hoy basis
Ensure that all operators are aware of the allowances given for breaks and shutdowns
Ensure that the start –up times and shutdown times are strictly adhered to
Conduct back to work interviews and monitor negative trends together with technical
Coordinator monitor daily efficiencies and output on a daily basis
Manage breakdowns

Perform basic maintenance of all equipment over all the area in filling by doing self-repairs or in consultation with Technical Coordinator / Maintenance department
Monitor breakdowns and ensure that action is taken by the Engineering department to determine the root cause of the breakdown and that equipment
Decide on when to perform a self-repair
Decide if equipment is fit to operate to the correct levels efficiency recommended
Process Control

Ensure that the production documents, including work instruction are available on the production line at all times
Decides whether production control is adequate
Calibration of instruments and measuring devices

Ensure that all instruments and measuring devices are identified and are within calibration
Decides whether measuring instruments are appropriate and fit for use
Manufacturing process

Completes the nightshift instruction per SOP 16-08-06-046
Set –up production line per SOP 16-08-06-046
Ensuring that the correct equipment is set up and that it is in good working order and that the production line is ready to start at the beginning of the shift
Perform a line clearance per SOP 16-08-06-046
Before filing commences ensure that filters are set –up per the nightshift instruction and the ‘Before Use” filter integrity test has been performed and that the filter has passed
Checks that the lines were sanitized per SOP 16-06-19-055 and SOP 16-08-06-046
Ensure that the correct parameters are used on the machine per SOP 16-08-06-046
Ensure that the material used is released and per the bill of material
Ensure product identification and traceability and preservation is maintained
Completes the labour sheets and / production notes
Decides whether the equipment is fit for use in Production
Decides on whether the machine can start sunning
Decides whether the filter configuration is per SOP 16-08-06-046
Decides whether adequate sanitization was carried out and on the action to be taken in case of non-conformance
Maintain a good IR climate

Ensure that discipline is maintained in the department
Decides on action to be taken based on the organisation’s Health Care policies
Competence, Awareness and Training (SOP 20-06-08-002)

Ensures that personnel performing the work product quality shall be competent on the basis of appropriate education, training, skills and experience
Maintains appropriate records
Using the training needs analysis decided who needs training and what training is required
Monitor compliance with the requirements of cGMP in the manufacturing environment

Ensure that GMP requirements per the organisation's requirements are applied in all areas where appropriate
Decides what GMP standards are met and action to be taken in case of non-compliance
Compliance to relevant sections of the OSHAct and SHE (Safety, Health and Environment) requirements

Ensure conformance to the OHSAct and the organisation's, SHE procedures
Ensures that JSO’s, Safety checks and talks are conducted and the necessary safety measures are implemented
Decides whether safety standards are being met
Decides on whether Operators are competent to operate machinery
Comply with the requirements of the organisation’s quality management system

Ensure that the conduct of the QMS is understood and practice for relevant sections
Reports any concerns of incompetency to the Technical Coordinator
Control of the organisation’s document management systems is applied as required

Ensure communication of the new updates / changes to SOP / SPECS
Ensure correct use and filling is practical
Ensure all routine documentation is present, activities recorded, signed and dated as tasks are completed.
Review all relevant batch documentation and signs and dates as applicable
Decides whether documentation is up to the correct standard of recording to assist efficient batch release
Corrective and Preventative Actions

Ensure that the necessary corrective action is taken to eliminate the cause of non-conformance in order to prevent recurrence
Contributes to problem solving sessions
Audits

Prepares for Audits and ensures compliance to standards
Participates in internal and external audits
Core Competencies

Basic business acumen
Self -Management
Attention to detail
Verbal comprehension
Verbal and written communication skills
Rule-orientation
Building the Brand (PRIDE)
Organisational awareness
Engaging diversity
Business insight
Decisiveness and Action Orientation
Drive to succeed
Teamwork
Planning & organising
Supportive orientation
Ethical responsibility
Presentation skills
Stress handling
Numerical reasoning
Monitoring
Analysis
Excellence
Assess
Collaborate
Influencing
Qualifications:

B Pharm / Engineering Diploma and /or Production Management beneficial or equivalent
Experience:

Between 3 – 6 years Production experience
Salary: 750 – 800K (negotiable on experience, qualifications and skills)