- Centurion, Gauteng
- Centurion, Gauteng
Job DescriptionThe job:
The Quality Manager will 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 clients standards at all times. You are someone who is independent in carrying out assigned tasks listed below and is expected to practice continuous improvement and self-training on our quality management system
Division Specific Information
Thermo Fisher Scientific, Clinical Trials Division, Gauteng, South Africa
What will you do?
- Responsible for overall site quality system compliance, conformance to quality requirements and specifications, and conformance to customer quality requirements.
- 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.
- Holds responsibilities as the Management Representative for Fisher Clinical Services South Africa’s quality system, and ensures the systems are managed and maintained effectively in accordance with the relevant standards.
- Maintaining and improving a Quality Management System through the provision of appropriate, cost effective and robust quality systems & support services
- Responsible for the creation, management, and adherence to Quality procedure and management of site training program.
- Engage in daily oversight and guidance of problem requests, complaint records, corrective and preventive actions, and change controls to drive on-time and scientifically sound closure
- Drive operational performance by identification, monitoring, and trending of quality metrics.
- Collaborate across functions and sites to troubleshoot problems, interpret data and resolve next steps based on a risk-based approach.
- Support liaison with clients and key suppliers on audit and quality-related matters and to provide guidance and advice to clients, suppliers and internal associates on quality matters.
- Identification, validation and qualification of facilities/equipment, inclusive of the review and approvals of validation related reports.
- Manage internal self-inspections program and support management of external supplier audits as per yearly schedule.
Who we are looking for:
- Tertiary Qualification in Health Science, Pharmacy, or equivalent.
- Experience in supplier management and supplier auditing will be advantageous.
- 3 years’ experience preferred in the pharmaceutical industry.
- 2 years’ experience preferred as a Quality Assurance.
- 2 years’ management experience preferred.
Knowledge, Skills, Abilities
- 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.
- Position requires good organization skills as well as good written and oral communication skills.
- Detail oriented with extreme accuracy.
- Strong digital literacy (Microsoft Office skills) with the ability to learn new software and tools quickly and experience in the pharmaceutical industry.
- Ability to think strategically with the capability to advise the resolution of technical problems using innovative ways.
- Work with diverse teams, guide teams through decision-making, facilitate agreement, build collaborative relationships and focus on customer needs.
- Highly skilled in Quality tools e.g. Risk Analysis, Root Cause Analysis.
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon
With Thermo Fisher Scientific, it’s not just a career. It’s a chance to realise your best – professionally and personally.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally ted status.