A Leading Pharmaceutical Company has a vacancy for a Production Manager

Key responsibilities:
Production planning to ensure that production takes place in a controlled manner according to SOP and according to the time schedule as agreed with the Service Providers:
Fill in Batch Manufacturing Records (BMR’s) for Standard codes in preparation for production.
Calculate raw material requirements for production, based on order from dispensary and on stock already in the sterilisation process i.e. in transfer and workstation isolators
Ensure that the calculated required stock is drawn from the warehouse by the store man and that FIFO and FEFO is maintained.
Plan which batches and codes will be prepared in which workstation.
Plan the flow of work and sterilisation cycles to ensure adequate output of components from sterilisation cycles and to avoid transfer of stock between workstation isolators
Liaise with QC Supervisor and ensure that planning takes into account equipment that needs to be made available to ensure strict adherence to Validation and Calibration Schedule
Liaise with QC Supervisor regarding availability of media, and ensure that planning takes into account sterilisation of media and other components required, to ensure strict adherence to maintenance, Validation and Calibration Schedules as per SOP requirements

Supervision of sterilisation cycles and transfer of material into and out of isolators:
Clearly direct packers in terms of which products to prepare and pack into which transfer isolator as per production planning
Ensure that product and components intended for use in production process is prepared according to SOP.
Check and sign off sterilisation logs after cycles have been packed, to verify the correct dilution of acid and that loading patterns comply strictly with sterilisation principles and SOP requirements
Ensure that correct docking and off-loading procedures are complied with, to maintain sterility and prevent any damage to equipment

Supervision of Compounding:
Ensure adherence to correct procedures for working in isolators (including not overloading workstations) by all staff according to SOP and GMP requirements
Ensure compliance of individual compounders to good aseptic mixing techniques as per SOP and GMP requirements
Verify and sign, as legally authorised person, for the addition of all components required in the compounding process as per SOP and GMP requirements
Oversee and ensure strict adherence to maintenance schedules by production staff

Oversee preparation of final product for QC check and gamma irradiation:
Ensure that final product is transferred appropriately from isolator clean room to packaging area and is prepared appropriately and timeously for QC check as per SOP
Ensure that production staff is used appropriately to timeously complete the packing of final product, in preparation for delivery to gamma irradiation site, after QC check on final product as per SOP and GMP requirements

Environmental control:
Ensure that the production area and packing areas are kept neat, clean and in compliance with good manufacturing practice guidelines at all times
Ensure that all production staff handle equipment with extreme care and respect to minimise costs involved with repairs and replacement of equipment
Record, and appropriately report, out of limit production related situations to the Services Manager and quality related situations to QC Supervisor.
Ensure that all workstations have been cleaned after the compounding shift and that the cleaning has been verified by a QC check before transferring new sterilised product into it.
Ensure that production staff adheres to prescribed hygiene and dress code as per SOP and GMP requirements including no eating, chewing of gum, drinking and smoking in classified areas

Electronic production management:
Ensure that all jobs are created timeously in ‘syspro’.
Ensure correct allocation of raw materials to jobs
Ensure that all jobs are receipted correctly post production

General:
Any additional duties relating to the smooth functioning of the company, when requested by senior management.
Ensure correct use, completion and filing of relevant documentation.
Participate in performance appraisal programs for subordinate staff
Co-ordinate, supervise and control overtime of production staff
Submit relevant stock counts and monthly stats to Services Manager.
Co-ordinate, schedule and perform GMP and quality training of production staff with QC Supervisor.
Co-ordinate, schedule and perform SOP training of production staff with QC Supervisor.

Experience:
At least 3 – 5 years’ experience will be advantageous

Qualifications:
BPharm degree
Registration with SAPC
Minimum 3 years production supervisory/management experience of at least 3 or more employees

Competencies & Knowledge:
Thorough knowledge of GMP and GDP

Skills:
Computer skills (MS Word and Excel)
Good technical skills
Problem solving
Excellent interpersonal skills
Self-motivator and Quality orientated

Attributes:
Responsible
Deadline driven
Enquiring mind with attention to detail
Able to function effectively under pressure

Should you receive no response within 7days, please consider your application unsuccessful