QC Raw Materials Manager

Recruiter:

Dalitso

Job Ref:

1591951656

Date posted:

Tuesday, September 14, 2021

Location:

Midrand, South Africa

SUMMARY:
-

POSITION INFO:

Ensure that departmental standard operating procedures are reviewed and updated timeously.
Master material specifications and analytical methods are in line with the latest Pharmacopeia references and regulatory documentation.
Standard operating procedures are representing actual events and comply with cGMP/GLP requirements.
Decide whether changes to documentation are acceptable in line with GLP.
Ensuring that all departmental SOPs are continuously updated with current requirements for GMP.
Requirements for GLP are documented in SOPs and QC Lab personnel are effectively trained and competent.
Ensure GMP, GLP, and safety standards are adhered to within the laboratory.
Compliance with SAPHRA and health and safety requirements.
Responsible for identifying training needs of direct reports.
Ensures that staff receive required initial and continued training and assessment and that training records are kept.
A continuous and periodic formal assessment of the performance of employees.
Ensure continuous feedback and communication to staff.
Manpower Retention
Submit an annual budget for the department.
Expenditure remains within budget.
Decide whether overtime is necessary when required.
Ensure that lab resources are effectively utilised and robust systems are implemented to ensure timeous testing and release of raw materials as per production plans and market demand.

Minimum Requirements:

BSc or National Diploma in Chemistry or related
8 years’ Laboratory experience in the pharmaceutical manufacturing industry
QC Laboratory supervisory experience is required.
A good understanding of cGMP and GLP is required.
Familiarity with equipment installation and qualification.
Experience in LIMS
Experience interacting with regulatory bodies.
Computer literacy/MS Office
Understanding of data integrity
Understanding of SAHPRA and WHO requirements

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