Job Description

At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds have a unique story to tell. Join us and contribute to 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 challenging 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.

Thermo Fisher Scientific provides industry leading pharma services solutions for drug development, clinical trial logistics and commercial manufacturing to customers of all sizes through our Patheon brand.

The job:

Your main responsibility is to ensure our quality management system remains up to date and adhered to through our quality policies/procedures and to ensure they are always maintained to Fisher Clinical Services Global quality and/or our clients' standards. You will be independently carrying out the assigned tasks listed below and are expected to practice continuous improvement and self-training on our quality management system

What will you do?

• Work closely with Production and Quality teams to resolve quality-related issues arising from customer complaints/concerns and internal incidents. Responsible for the facilitation of investigations and resolution of related quality issues.
• Identify and Provide training to ensure compliance with company’s procedures and regulatory standards.
• Supports QA review of GMP Facilities documentation including equipment, computerized systems and utility qualification and validations protocols and reports; and, calibration, preventative maintenance and monitoring records.
• 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.
• Assists in QA robust document review and approval activities to meet specified timelines and ensure adherence to Quality Agreements, regulatory requirements and site procedures. Tracks review and cycle times of relevant records. Documentation may include batch records, SOPs, and technical documents following site procedures.
• Preparing the annual internal audit plan in conjunction with the QA Manager, scheduling audits according to the plan and ensuring that audits are resourced, conducted, and followed up on time; with the potential for assisting in the audits themselves.
• Support external supplier audits and supplier training.
• Provide guidance in all areas of the Quality Management System, including, corrective & preventive actions, product complaints, change control, investigations, risk management, and audit support functions.
• Performs quality review and approval of Secondary Packaging Production Jobs.
• Identify and implement improvements using quality data, metrics, and business tools.

• Bachelor's degree in Pharmacy
• Active Registration as a Pharmacist at the South African Pharmacy Council
• Experience in Regulatory Requirements and Quality Assurance will be advantageous.
• A minimum of 2 years experience in the pharmaceutical industry.

Knowledge, Skills, Abilities

• Ability to work independently and be self-motivated with a positive demeanor.
• Ability to work under pressure and consistently meet tight target timelines.
• Effective time management and prioritization skills.
• Meticulous with exceptional accuracy.
• Strong digital literacy (Microsoft Office skills) with the ability to learn new software and tools quickly.