Position Objective:
The purpose of this position is to ensure all Fisher Clinical Services Manufacturing (FCSM) activities are performed in compliance with the local Quality Management System, local regulations, client requirements and relevant cGMP standards.
The Responsible Pharmacist, with limited supervision, will have full oversight of the FCSM facility through appropriate training on software tools and Standard Operating Procedures.
The Responsible Pharmacist is appointed for the management and coordination of secondary packaging / labelling activities, including the receipt, storage and distribution of products within the scope of license capabilities, hold responsibility for the safety, quality and efficacy of all material within the premises, and safeguarding product against potential hazards arising from poor practices.
Ensures the conditions of the applicable regulatory licenses, Good Manufacturing Practice (GMP) guidelines and regulatory guidelines as set out by the South African Health Products Regulatory Authority (SAHPRA) and South African Pharmaceutical Council (SAPC) are always upheld .
The holder of this position is independent in carrying out assigned tasks listed below and is expected to practice continuous improvement and self-training on our Quality Management System.
What will you do?
- Ensure compliance to regulations and guidelines as determined by the local competent authorities, including South African Health Products Regulatory Authority (SAHPRA) and South African Pharmacy Council (SAPC).
- Delivering high standards of pharmaceutical care for the end-to-end management of operations in accordance with Good Pharmacy Practice (GPP) and Good Manufacturing Practice (GMP).
- Management and coordination of facility registrations and licenses, review of GMP Facilities documentation, including equipment, computerized systems and utilities qualification and validations protocols and reports.
- Work closely with Production and Quality teams to resolve quality related issues arising from customer complaints / concerns and internal incidents.
- Performs quality assessments of facility, personnel, and documentation to uncover errors or deficiencies and assure quality and compliance as required by site procedures and cGMPs.
- Maintaining the FCSM Site Master File and Pharmaceutical Management System.
- Identify and provide training ensure compliance to the company’s procedures and regulatory standards.
- Management and coordination of secondary packaging / labelling activities, including the receipt, storage and distribution of products.
- Oversee batch recall procedures.
How will you get here? Education
- Bachelor's degree in Pharmacy.
- Active Registration as a Pharmacist at the South African Pharmacy Council.
- A minimum of 2 years’ experience in production/manufacturing (GMP).
- Experience as a Responsible Pharmacist will be advantageous.
- Experience in Clinical Trials will be advantageous
Knowledge, Skills, Abilities
- Excellent legislative knowledge, i.e., Pharmacy Act, Medicines & Related Substances Act, SAHPRA, GMP, GCP.
- Ability to work independently and be self-motivated with a positive attitude
- Ability to work under pressure and meet tight deadlines
- Effective time management and prioritization skills.
- Technical minded, Detail oriented with extreme accuracy.
- Strong digital literacy (Microsoft Office skills) with the ability to learn new software and tools quickly.
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