PRINCIPLE DUTIES

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

QUALIFICATIONS REQUIRED

Bachelors Degree in Pharmaceuticals or Chemistry is essential

KNOWLEDGE REQUIRED

Excellent Computer Skills (MS Office especially)
Excellent knowledge of Business Principles (essential)
Knowledge of cGMP regulations and Regulatory Requirements (Essential)

EXPERIENCE REQUIRED

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

SKILLS REQUIRED