Production Manager-Pharma

2 weeks ago

Johannesburg, Gauteng, South Africa Stafflink Recruitment Solutions Full time

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 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. BMRs & 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.

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