Key Job Responsibility:
To manage operations within the production department to ensure maximum output of anti-venom products cost effectively and in accordance with Medical Control Council and SA pharmaceutical requirements.
To implement QA process and SOPs in compliance with Good Manufacturing Practice (GMP) to ensure the production of safe, efficacious and quality products.
Ensuring compliance of the Quality Management System.
Coaching of the staff.
To oversee and monitor equipment calibration and maintenance, liaising with external contractors to ensure that maintenance and validation schedule is adhered to.
To manage assets (including Capex) and the procurement of consumables for seamless operation, plan for CAPEX and monitor stock levels of consumables.
To generate and review management report, preparation of all management reports pertaining to the production department and to ensure that information is shared with other departments.
Coaching/Training, performance review and appraisals for staff, all staff undergoes continues training, train staff on all SOP,s and ensure competence in their understanding of policy and keep them up to date with current GMP requirements.
Safety to ensure that the department operates within OHSA requirements in order to maintain a safe workplace.
Documentation, compile SOPs and production-related documents to comply with GMP regulations, plan monthly and weekly production schedule, review equipment logbooks and rooms.
Oversees and trains staff.
Manages, monitors, controls stock, workflows and turnaround times.
Management of quality system including the implementation of appropriate quality assurance procedures, audit the Quality Control (QC) results and takes the appropriate action.
Manage SANAS accreditation requirements.
Minimum requirements & key competency:
Four(4) year Degree/Diploma in Pharmacy(B.Pharm)
Registration with South African Pharmacy Council as a Pharmacist
Six(6) years Pharmaceutical manufacturing industry
One (1) year Aseptic processing
Two(2) years Supervisory experience in the pharmaceutical industry.
Knowledge of GMP requirements
Knowledge of aseptic technique
Knowledge of sterilization methods
Knowledge of validations
Basic Financial Knowledge
Knowledge of OHSA
Computer Skills
General Management Skills
Communication skills
Interpersonal skills
Problem solving and trouble shooting skills
Attention to detail.
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