Job Purpose:
Manages manufacturing operations as per the agreed supply plan in accordance with legal pharmaceutical requirements and duties and ensures compliance within the Value Stream.

1. QUALITY / GMP & COMPLIANCE
Ensures products are manufactured to the required quality and compliance standards.
1.1 Ensures compliance with relevant quality, compliance legislation, SOP’s olicy within the Value Stream.
1.2 Prepares and reviews SOP’s in accordance with above standards and also manufacturing procedures and packing documentation.
1.3 Ensures GMP by maintaining production area and equipment in a clean and good working order; maintaining tidiness and minimising cross
contamination risks; liaising with Central Engineering and Packaging Manager as to maintenance and repair of machines and building.
1.4 Performs self audits in Value Stream.
1.5 Participates in factory wide internal audits.
1.6 Represents the Value Stream in external compliance audits.
1.7 Performs required Process Validation and Cleaning Validation findings as per the Validation Master Plan.
1.8 Complies with Change Control requirements.
1.9 Conducts staff training on execution of SOP’s.
1.10 Manages & over-sees manufacturing operations & ensures batches are manufactured according to registered methods.


4. PRODUCTION PLANNING AND SCHEDULING
Schedules agreed supply plan in conjunction with planners to optimise manufacturing operations to achieve maximum utilization of resources within the Value Stream.
4.1 Ensures that the manufacturing schedule is optimised to support the packing schedule.
4.2 Communicates progress against schedule timeously.
4.3 Tracks Shop Orders via Value Stream boards and ensures update of Router information on MRP system.
4.4 Ensures capacity is available, including people and equipment.
4.5 Liaises with support functions to facilitate the plan.

5. PRODUCTION
Executes Production activities in accordance with agreed supply plan.
5.1 Ensures availability of required resources to meet production schedule.
5.2 Optimises utilization of manufacturing resources to achieve cost efficient usage of labour, capacity and materials.
5.3 Drives performance to ensure that Production targets are met.
5.4 Supervises all stages of product manufacture and completes and approves all manufacturing and batch documentation.
5.5 Initiates trouble-shooting, problem solving and resolution of any obstacles in achieving agreed supply plan.
5.6 Approves commencement of packing runs after performing line clearance checks.
5.7 Completes and signs off packing documentation.
5.8 Investigates reconciliation discrepancies or other quality problems.
5.9 Liaises with QA Manager with regards to any quality or compliance problems during manufacture or packing.
5.10 Ensures that KPI’s are achieved.

Minimum of BPharm, BScPharm or Diploma in Pharm

EXPERIENCE:
Ideally 5 years experience within a manufacturing pharmaceutical environment, with some experience at a managerial level. However prepared to develop from within.