Salary: R1m-R1.3m CTC (cash plus pension) Location: Johannesburg
Description:
Primary Responsibilities
Managing the Manufacturing Department and Dispensary to ensure supply to internal and external customers.
Monthly capacity planning and production schedule according to the marketing division demand.
Executing and managing the production schedule and activities to achieve pre-determined monthly production targets.
Introducing new products within the facility and conducting trial and validation batches in conjunction with the Validation Department.
Assisting Validation with in-house and external calibrations of equipment.
Liaising with all functional departments and the Marketing Division on new product projects.
Opening manufacturing runs/lines and issuing raw materials.
Auditing and signing off batch manufacturing records (BMRs) and completing transactions on SAP.
Creating, updating training, and implementing standard operating procedures (SOPs).
Initiating change controls (CCs) to motivate changes to systems, procedures, or equipment.
Creating or updating BMRs for new products and amending existing documents where applicable.
Investigating non-conformances and out-of-specification (OOS) and compiling non-conformance reports (NCRs).
Compiling user requirement specifications (URSs) before ordering and installing new equipment.
Working closely with the engineering department maintaining equipment and addressing ad-hoc breakdowns.
Joining ownership of projects, e.g., Reverse Osmosis (RO) Water Plant Upgrade Project.
System ownership over the Reverse Osmosis water plant and ensuring daily monitoring.
Driving capacity improvement, process mapping, and production efficiency projects.
Involvement in facility and equipment upgrade projects.
Exercising strict control over Scheduled Substances and ensuring the scheduled substances register is up to date.
Ensuring GMP compliance and general production housekeeping.
Ensuring departmental safety and reporting issues to the engineering department.
Managing, motivating, and developing a production team to improve overall output and grow capacity.
Advising QA in quality risk assessments and conducting departmental risk assessments.
Assisting and advising the Regulatory Department on production issues or submissions of process changes/updates (CAPAs).
Compiling a monthly production report for management.
KEY KNOWLEDGE AND EXPERIENCE
B Pharm Degree.
Minimum 5-10 years of pharmaceutical manufacturing and packaging experience.
Knowledge of pharmaceutical manufacturing processes.
Experience in planning and scheduling production activities.
Experience in examining and updating operations and procedures and updating relevant GMP documentation e.g., BMRs & SOPs.
Ability to motivate teams to produce quality material within tight time frames and simultaneously manage several projects.
Auditing and report writing skills.
Ability to analyze problems, identify alternative solutions, project consequences of proposed actions, and implement recommendations in support of goals.