Sterility Assurance Laboratory Manager Jobs

  • Full Time
  • Permanent

Worker24

Sterility Assurance Laboratory Manager – Jhb

Introduction

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

Package & Remuneration

Salary:   Market related

Should you not hear from us within 2 weeks, kindly consider your application as unsuccessful.



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