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 more than $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.
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 and/or our clients 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?
- Applies Good Manufacturing Principles in all areas of responsibility
- Demonstrates and promotes the company vision and the 4I’s: Integrity, Intensity, Innovation and Involvement
- Conducts all activities in a safe and efficient manner
- Perform all processes in accordance to established procedures and cGMP standards.
- Maintains GPM systems to ensure standards relating to Good Distribution Practice and Health & Safety are complied with
- Arranges preliminary collection of necessary documentation (as contact information, shipping instructions, MSDS etc.) at the study start up stage
- Verifies and tracks incoming/outgoing shipments
- Monitors receipt of site shipments and returns
- Manage the Distribution mailbox
- Maintains shipping documents filing
- Data capturing of relevant paperwork to complete the clinical trial processes as applicable
- Ensures that clinical supplies are stored and distributed in accordance with Fisher Clinical Services approved procedures and policies, cGMP, cGDP and regulatory requirements
- Assist in maintaining the FCS South Africa Quality System in compliance with Fisher Clinical Services approved procedures and policies, cGMP, GXP and regulatory requirements
- Provide update to QA and rest of business units on the status of complaints, internal issues and quality metrics
- Perform self-inspections in area of responsibility
- Assist with batch recall procedures
- Participate and follow up on actions from monthly quality control monitoring
- Participate in study-related training
- Participate in and contribute to the development and achievement of the corporate goals and objectives
- Assist in the investigation of internal and external non conformances through to resolution where required
- Assist in the investigation of customer complaints through to resolution where required
- Assist in internal audits according to SOP requirement and assist in regulatory, supplier and client audits.
- Liaise closely with clients on return drugs & destruction
- Maintain the facility and ensure workspaces are clean, neat and tidy
- Maintain proper documentation for all processes conducted/performed
- Assist in Project Management – updating contract listings, update checklists, generate and compile reports as requested, archiving study files and corresponding on import documentation
- Assist management in any other matters as required
- Process all shipping distribution orders in a timely manner as required
- Complete the distribution check-list according to project instructions
- Prepare relevant documents according to country requirements and client instructions
- Complete documentation and update computer systems appropriately and correctly
- Perform any reasonable task, in line with the business’s goals, as requested by upward liaison on projects and improvement initiatives as required by Management.
- Participate in ad hoc assignments.
- Perform other duties that are commensurate with the job.
Key Performance Metrics in line with PMD:
- 100% achievement in meeting client study requirements.
- 100% accuracy in processing/handling of study records, reports and targets.
- Ensure a 100% achievement in area of responsibility.
How will you get there?
- Grade 12 / Matric.
- Applicable college degree in related field would be advantageous, (Customer Service, Office Administration).
Minimum Job Experience:
- Minimum of 4 years practical experience working within a high demand environment. (Medical/Pharmaceutical Advantageous).
- Proven skills — high attention to detail, meeting deadlines.
- Needs to be computer-literate and meticulous in his/her work
Basic Technical Skills:
- Proficient to Advanced Microsoft office skills. Excel, Word, Power Point, GPM.
- Internal, Customers, group & 3rd party suppliers.
Internal and External Contacts:
- General Manager, Operations Manager, Project Manager, Distribution Services Associate, Warehouse Technicians, Quality Manager, Personnel across all Fisher Clinical Services and Fisher Clinical Logistics sites.
- Manager – Client Services, Director – Supply Chain, Clients, Courier Companies, Distributors of Commercial Medicaments, Brokerage companies, Destruction Companies, Local representatives of Pharma Companies and CROs.
- Ability to work under pressure and to support others within the team.
- Excellent written and verbal communication both internally and externally.
- Extensive spreadsheet analysis and strong mathematical abilities.
- Ability to co-ordinate various processes simultaneously.
- Detail oriented with extreme accuracy.
- Teamwork. Ability to influence across functions to achieve objectives.
- Flexible and adaptable, with strong customer orientation skills.
- Problem solving
- Follow up
- Time management
- Good communication skills
- Customer service
- Telephone etiquette
- Financial orientation