POSITION : PRODUCTION PHARMACIST – SOLIDS MANUFACTURING
REPORTS TO : TECHNICAL EXECUTIVE
DIVISION : ISANDO

JOB OBJECTIVE

• Provide leadership and coordination of Solids Manufacturing Department functions.
• Produce products according to Marketing Divisions demand.
• Plan and Schedule the department’s monthly activities.
• Ensuring the department's activities are aligned and suitably staffed
• Auditing departmental batch documentation (e.g. Batch Manufacturing Records (BMR's)) to ensure that product specifications are met during manufacturing
• Performance Management
• Update Standard Operating Procedures (SOP's) and ensure that the staff are trained on the updated versions

TASK DESCRIPTION

• Managing the Manufacturing Department and Dispensary to ensure supply to internal and external customers.
• Monthly capacity planning and production scheduling according to the Marketing Division’s demand.
• Executing and managing the production schedule and activities in order 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 and advising Validation Department with product technical transfers and in-house and external calibrations of equipment.
• Opening manufacturing runs/lines and issuing raw materials.
• Auditing and signing off batch manufacturing records (BMR’s) and completing transactions on SAP.
• Creating, updating, training and implementing standard operating procedures (SOP’s).
• Initiating change controls (CC’s) in order to motivate for changes to systems, procedures or equipment.
• Create and update BMR’s for new products and amend existing documents where applicable.
• Investigating non-conformances and out of specifications (OOS) and compiling non-conformance reports (NCR’s).
• Working closely with engineering department in maintaining equipment and addressing ad-hoc breakdowns.
• Driving of capacity improvement, process mapping and production efficiency projects.
• Exercising strict control over Scheduled Substances and ensuring that the scheduled substances register is up to date.
• Ensuring GMP compliance and general production area 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.
• Advise QA in quality risk assessments and conduct departmental risk assessments.
• Assist and advise Regulatory Department on production issues or submissions of process changes/updates.
• Attending to internal and external audit and responding with corrective actions and preventative actions (CAPA’s) and compiling a monthly production report to Management

EDUCATION AND KEY EXPERIENCE

• B.Pharm Degree
• Minimum 4 – 6 years 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 to update relevant GMP documentation e.g. BMR's & SOP's
• Work requires professional written and verbal communication and interpersonal skills.
• Ability to motivate teams to produce quality materials within tight timeframes, simultaneously manage several projects and participate in and facilitate group meetings
• Ability to delegate authority and responsibility
• Ability to Analyse problems, identify alternative solutions, project consequences of proposed actions and implement recommendations in support of goals.