Current Vacancies at Thermo Fisher Scientific

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.

How will you get here?

• 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.

go to method of application »

The Job:

The purpose of a quality controller is to ensure our quality management system remains up to date and adhered to through our quality policies/procedures and to ensure they are maintained to Fisher Clinical Services Global quality and/or our client's standards at all times, 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:

• Adhere to Good Manufacturing Principles and Good Wholesale Practice Principles.
• Offer expertise and assistance on quality-related matters to ensure a cohesive team effort.
• Assist Quality Management in all document control activities and ensure compliance with policies and procedures throughout the business. Stay updated on industry standards and legal requirements to ensure compliance.
• Handle administrative tasks related to quality system management, including but not limited to document control (writing procedures, creation of forms, etc., ), data analysis, and report generation.
• Participate in the management of non-conformances and corrective actions.
• Encourage and support initiatives aimed at improving quality standards consistently.
• Participate in ensuring the effectiveness and efficiency of the quality management system in place.
• Set and strive to meet quality performance goals.
• Collaborate with operational teams to develop and implement effective quality procedures.
• Conduct training sessions to enhance employees' understanding of quality standards and practices. Ensure training compliance and timelines are adhered to throughout the business.
• Participate in self-inspections as per the approved program.
• Lead the management of Supplier Training and supplier tasks.
• Perform Quality Control checks in the execution of pharmaceutical secondary packaging jobs for clinical trials.

How will you get here?

• A minimum of 2 years experience in the pharmaceutical/health industry.
• Experience in Pharmaceutical Regulatory Requirements will be advantageous.
• Experience with ISO: 13485 will be advantageous.

Knowledge, Skills, Abilities

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