Manufacturing Manager - Pharma

SUMMARY:
Isando

POSITION INFO:

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 (SOP’s)
• Initiating change controls (CCs) to motivate FOR CHANGES to systems procedures or equipment.
• Create on update BMRs for new products and amend 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.
• Join 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 are 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.
• Advice QA in quality risk assessments and conduct departmental risk assessments
• Assist and advise 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
• Experiencing in examining and updating operations and procedures and updating relevant GMP documentation e.g. BMR’s & SOPs
• Ability to motivate teams to produce quality material within tight time frames and simultaneously manage several projects
• Auditing and report writing skills
• Analyse problems, identify alternative solutions project consequences of proposed actions, and implement recommendations in support of goals.