Production Pharmacist

Position overview

• An opportunity is available for two Production Pharmacists to join a pharmaceutical manufacturing team in Clayville. The successful candidates will provide pharmaceutical and technical oversight of manufacturing and packaging operations, ensuring that products are manufactured, packaged and documented in accordance with Good Manufacturing Practice (GMP), SAHPRA requirements, approved procedures and product specifications.
• The role requires strong manufacturing knowledge, attention to detail and the ability to maintain regulatory compliance, support quality initiatives and drive continuous improvement within the production environment.
• Applications are open to all suitably qualified candidates, with preference given to candidates from designated groups.

Key responsibilities

GMP compliance and production oversight

• Ensure manufacturing activities comply with current GMP, SAHPRA requirements, approved SOPs, master batch manufacturing records and registered product specifications.
• Monitor production operations to ensure compliance with quality, safety and regulatory requirements.
• Maintain production areas in a state of inspection readiness.
• Verify that line clearance activities are completed and documented before production begins.
• Ensure appropriate segregation, identification and status labelling of materials and products.
• Promptly report and address out-of-specification results and quality concerns.
• Ensure manufacturing and packaging activities are not performed under non-compliant environmental conditions.
• Verify that daily checks of scales and balances are completed and documented before production activities commence.
• Ensure out-of-calibration scales are clearly labelled, removed from use and appropriately segregated.

Batch documentation and record review

• Review completed batch manufacturing records for accuracy, completeness and GMP compliance.
• Ensure production records are completed contemporaneously and meet data integrity requirements.
• Verify reconciliation of materials, yields and packaging components.
• Ensure production documentation is controlled, retained and archived in accordance with company procedures.

SOP development and document management

• Draft, review and update SOPs, work instructions, batch manufacturing records and other GMP documentation.
• Ensure production procedures remain current, effective and compliant with regulatory requirements.
• Participate in periodic reviews of SOPs and manufacturing instructions.
• Coordinate the controlled implementation and communication of revised procedures.
• Provide technical input into new procedures and process improvements.

Deviations, investigations and CAPA

• Investigate production deviations, non-conformances and quality incidents.
• Conduct root cause analysis and implement corrective and preventive actions (CAPAs).
• Support investigations involving out-of-specification and out-of-trend results, customer complaints and product quality concerns.
• Monitor the effectiveness of implemented corrective and preventive actions.

Validation and continuous improvement

• Support process validation, cleaning validation and equipment qualification activities.
• Participate in risk assessments and change control processes.
• Identify opportunities to improve manufacturing efficiency while maintaining product quality and compliance.
• Facilitate continuous improvement initiatives within production.

Training and competency management

• Ensure production personnel are trained and competent in GMP, SOPs, manufacturing processes, data integrity and health and safety requirements.
• Conduct SOP and GMP training as required.
• Maintain accurate training records and monitor training compliance.

Audit and regulatory support

• Participate in internal, customer and regulatory audits.
• Support responses to audit findings and the implementation of corrective actions.
• Maintain audit readiness within production areas.
• Assist during SAHPRA, customer and third-party inspections.

Health, safety and environmental compliance

• Ensure compliance with occupational health and safety requirements.
• Promote a culture of safety, quality and regulatory compliance.
• Report and investigate safety incidents within the production environment.

Minimum requirements

• Bachelor of Pharmacy (BPharm).
• Registration with the South African Pharmacy Council (SAPC).
• 3–5 years' experience in pharmaceutical manufacturing.
• Experience in solid dosage, liquids, creams or sterile manufacturing environments.
• Experience with GMP systems and regulatory inspections.
• Experience in SOP development and document control.
• Technical knowledge and skills
• SAHPRA regulations and PIC/S GMP guidelines.
• Pharmaceutical manufacturing processes.
• Batch documentation and record management.
• SOP writing and revision.
• Risk management principles.
• Deviation and CAPA management.
• Root cause analysis.
• Process validation.
• Data integrity requirements.
• Microsoft Office Suite.

Required competencies

• Strong analytical thinking and problem-solving abilities.
• Sound decision-making and attention to detail.
• Business acumen and results orientation.
• Effective communication and relationship management.
• Influencing and negotiation skills.
• Customer focus and ethical conduct.
• Resilience, agility and a continuous improvement mindset.
• Ability to support and develop production teams.