Sterility Assurance Laboratory Manager
| Location | Johannesburg, South Africa |
| Date Posted | October 14, 2020 |
| Category |
Health Care / Medical
|
| Job Type |
Full-time
|
| Currency | ZAR |
Description
Purpose:
A well-known pharmaceutical organisation is urgently seeking Sterility Assurance Laboratory Manager who will be responsible management the sterility assurance laboratory, manage the various activities within the laboratory (environmental monitoring/sterility evaluation/steriliser qualifications/ finished product testing) and staff related functions
Duties & Responsibilities
Key Job Outputs:
- Determines the required staff complement to adequately man the department
- Recruits, appoints and monitors staff performance periodically
- Ensure that discipline is maintained in the department
- Ensures that personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience
- Ensures that the required initial and continuing training of departmental personnel is provided and the effectiveness is evaluated
- Maintains appropriate records
- Develop key personnel to function effectively and ensures adequate back-up
- Prepare, monitor and control the relevant department expense and capital expenditure budget
- Monitor compliance with the requirements of cGMP and cGLP in the manufacturing and testing environment
- Comply with the required SHE (Safety, Health and Environmental) requirements
- Comply with the requirements of the organisation’s quality management
- Complies with the organisation’s document management system
- Ensure that all the necessary testing is performed according to the appropriate procedures
- Ensure that all the necessary testing is carried out
- Ensures action to complete customer complaints covers all the necessary testing
- Ensures that product which does not conform to requirements is identified, controlled and prepare reports for investigation
- Ensures that the necessary corrective action is taken to eliminate the cause of non-conformities in order to prevent recurrence
- Ensures conformity of product and continually improving the effectiveness of the quality management system
- Ensure that product validations are performed in accordance with SOP
- Ensure that all sterility functions are carried out according to guidelines
- Maintains all processes required for the sterility assurance system
- Ensures that changes are reviewed, verified and validate, as appropriate, and approved prior to implementation
Core Competencies:
- Attention to detail
- Verbal and written communication skills
- Good record keeping
- Team player
- Innovative
- Stress handling
- Goal driven
Desired Experience & Qualification
Qualifications:
- Grade 12
- BSc Degree or National Diploma in Microbiology/Biotechnology/Medical Technology
Experience:
- Laboratory Bench work in the Pharmaceutical Industry a Must
- Supervisor / Managerial experience a Must
- Computer literate
- 2 years’ experience in a pharmaceutical industry a Must