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. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
Business Unit Objectives :
Fisher Clinical Services South Africa is responsible for ensuring clinical trial product is delivered in accordance with the company or clients specific policies and procedures within client delivery time lines.
The Quality Assurance Manager will, with limited supervision and with appropriate training on software tools and processes, be capable of coordinating and managing the Quality Management System to high levels of accuracy, have the knowledge and confidence to identify areas for improvement and with limited oversight develop solutions to achieve our quality service goals.
Fisher Clinical Services South Africa is a team environment. We need people who work well with others, whether in meetings, face-
to-face, on the phone, or on email. Successful candidates are self-motivated, are willing and able to do whatever is required to meet our customers’ needs, have solid interpersonal skills, are fast learners with the ability to adapt very quickly to change and get ahead of issues and problems are essential characteristics, Solid technical skills must be demonstrated or quickly learned, including proficiency in Office computer software and the software systems used in our organization.
Position Summary :
The purpose of this position 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, our clients and regulatory 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.
Main Activities / Responsibilities :
Applies cGMP and cGxP Principles in all areas of responsibility.
Demonstrates and promotees the company vision of the 4I's : Integrity, Intensity, Innovation and Involvement.
Conducts all activities in a safe and efficient manner.
Ensure compliance with applicable Corporate and Divisional Quality Policies and procedures.
Holds responsibilities as the Management Representative for Fisher Clinical Services South Africa’s quality system, safety management system, and ensures the systems are managed and maintained effectively in accordance to the relevant standards.
Responsible for the compliance of Fisher Clinical Services South Africa to established quality procedures to cGMP & cGxP standards in relation to the clinical supply chain activities in South Africa
Responsibility for management of non-conformances (deviations, complaints and quality investigations) and related corrective and preventive actions through to resolution
Leads 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.
Leadership role in service and quality improvement initiatives in line with other functional units, to improve market competitiveness.
This covers equipment as well as processes.
Driving a culture of continuous improvement through the information generated by compliance monitoring and cGMP requirements
Establishing and maintaining a Quality Management System through the provision of appropriate, cost effective and robust quality systems & support services
Promoting quality achievement and performance improvement throughout the organization.
Develop, implement, communicate and maintain a quality plan to bring the Company’s Quality Systems and Policies into compliance with quality system requirements.
Ensuring compliance with national and international standards and legislation.
Formulate and manage the development and implementation of goals, objectives, policies, procedures and systems pertaining to the QA / QC.
Defining quality procedures in conjunction with operating staff.
Identifying relevant quality-related training (QA / GMP) and provide training for employees across the company
Collating and analyzing performance data and charts against defined parameters.
Perform internal self inspection as per yearly schedlue
Manage external supplier audits as per yearly schedlue
Participate and follow up on actions from monthly quality control monitoring
Assist in the investigation of customer complaints through to resolution where required
Contribute in weekly and monthly management meetings.
Minimum Requirements / Qualifications :
Grade 12 / Matric.
Quality related qualification.
Professional background in Quality Management or related subjects.
Minimum 5-6 years’ experience holding a similar management position within a quality management environment.
Sound Knowledge of ISO quality systems
Other skills :
Strong problem solving skills
Good verbal and written communication skills,
Ability to work across all levels, functions and regions and cross-functionally.
Demonstrate organizational skills with the ability to handle multiple tasks with different priorities
Excellent inter-personal, self-motivational and negotiating skills
Proficient to Advanced Microsoft office skills. Excel, Word, Power Point
Good English skills, both verbal and written
Ability to work under pressure and to support others within the team.
Good English skills both written and verbal communication,
Computer, analytical problem solving, planning / organizational, interpersonal / teamwork, negotiation and leadership skills are necessary.
Extensive spread sheet analysis and strong mathematical abilities.
Ability to co-ordinate various processes simultaneously.
Detail oriented with extreme accuracy.