Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
About Thermo Fisher Scientific:
At Thermo Fisher Scientific, each one of our extraordinary minds have a unique story to tell. Join us and be part of our singular mission-enabling our customers to make the world healthier, cleaner and safer.
When you're part of Thermo Fisher Scientific, you'll do exciting work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best providing industry leading pharma services solutions for drug development, clinical trial logistics and commercial manufacturing to customers of all sizes, through our Patheon brand.
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Thermo Fisher Scientific is committed to a fair and inclusive work environment.
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 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, holds responsibility for the safety, quality and efficacy of all material within the premises, and safeguarding product against potential hazards arising from poor practices.
The holder of this position is independent in carrying out assigned tasks listed below and is encouraged to practice continuous improvement and self-training on our Quality Management System.
What will you do?
- We 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).
- We deliver high standards of pharmaceutical care for the end-to-end management of packing and labeling 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.
- We work closely with Production and Quality teams to resolve quality related issues arising from customer complaints / concerns and internal incidents.
- Performing quality assessments of facility, personnel, and documentation to uncover errors or deficiencies and assure quality and compliance at all times as required by site procedures and cGMPs.
- 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.
- Lead all aspects of batch recall procedures.
How will you get here?
- Bachelor's degree in Pharmacy.
- Experience as a Responsible Pharmacist will be conducive.
- Experience in Clinical Trials will be conducive
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 demeanor
- Technical minded, Detail oriented with effective time management and prioritization skills.
- Strong digital literacy (Microsoft Office skills) with the ability to learn new software and tools quickly.
- Ability to work efficiently and meet timelines