Operations Lead Midrand

Operations Lead

The Operations Lead will be based in Midrand and responsible for ensuring optimum utilisation of all laboratory resources, quality, and timely results to customers.

The incumbent will be instrumental in securing the technical competency and relevance within the company in the current and any new analytical fields, which may be envisaged as part of its strategy. The incumbent will oversee all aspects of day-to-day laboratory operations ensuring accurate and timely results, while maintaining a safe and efficient work environment. The Operations Lead ensures the competitive positioning of the company as an independent analytical laboratory to satisfy the client's needs in accordance with the requirements of the South African Health Products Regulatory Authority and related international standards. This position will be responsible for all operations including insourced and outsourced operations.

Duties & Responsibilities

1. Enforce company policies and standard operating procedures in collaboration with the QA Manager.
2. General management of the analytical laboratory in terms of cGXP including following and enforcing all applicable regulations and requirements according to SAHPRA Guidelines.
3. Improve and promote quality and regulatory compliance, demonstrate accuracy and thoroughness throughout all other functions.
4. Verify and process supplier documents and approved supplier databases.
5. Draft and combine reports, verification of results, calculations, and raw data verification.
6. Ensure data integrity in compliance with ALCOA standards.
7. All People and Culture matters in collaboration with the People, Culture and Purpose Manager: Leave matters.
8. Participate in the recruitment of qualified team members.
9. Assist with the implementation of performance management leading to a positive and high-performance company culture.
10. Actively foster a culture of right first time and continuous improvement.
11. Build, influence and inspire the team to create an equitable environment that is conducive to personal and company growth.
12. Management of sub-contracted projects and outsourced services being responsible for results from contracting laboratories.
13. Qualification of service providers, sub-contractors, and suppliers as per the relevant SOPs.
14. Implementation and maintenance of the apparatus maintenance programme, reporting of problems with apparatus and arranging for repairs.
15. The maintenance of laboratory equipment, performance by establishing quality standards; developing operations, quality, and troubleshooting procedures; ensuring staff compliance; certifying instrument performance; arranging equipment replacement, service, and repairs.
16. Implementation and maintenance of the regular calibration of apparatus and calibration schedule in collaboration with the Shift Leaders and Team Leaders.
17. Oversee day-to-day operations.
18. Ensure the implementation and maintenance of Health and Safety Regulations in the workplace.
19. Ensure the safety and security procedures for all equipment, materials, and activities on site.
20. Project management and control in collaboration with laboratory personnel.
21. Supervision of access to the laboratory.
22. Planning and execution of projects in collaboration with the QA Manager and Technical Director.
23. Supervision of waste management according to SOP.
24. Oversee and maintain the Stability Programmes.
25. Supervision and control of confidential information and documentation.

Desired Experience & Qualification

QUALIFICATIONS REQUIRED

• Bachelor's Degree in Pharmaceuticals or Chemistry is essential.

EXPERIENCE REQUIRED

• Minimum of 10 Years Laboratory experience is essential.
• Minimum 5 Years experience as Laboratory / Operations Lead is essential.
• Technical Document compilations, document control experience, and data integrity is essential.

KNOWLEDGE REQUIRED

• Excellent Computer Skills (MS Office especially).
• Excellent knowledge of Business Principles (Essential).
• Knowledge of cGxP regulations and Regulatory Requirements (Essential).