Job Description

The QC & Micro Laboratory Supervisor will be accountable for ensuring compliance through the effective implementation of laboratory systems in accordance with Good Laboratory Practices, GMP and ISO13485 standards and to provide laboratory testing services to both internal and external customers for the QC and Microbiology Functions. The QC & Micro Laboratory Supervisor will deputize for the Site Quality and Regulatory Leader / Management Representative (Responsible Pharmacist) in his/her absence from the office on all matters impacting on quality control. The Quality Control & Microbiology Laboratory Supervisor, Production Manager and the Site Quality & Regulatory Leader / Quality Management Representative (Responsible Pharmacist), generally have some shared, or jointly exercised, responsibilities relating to quality including in particular the design, effective implementation, monitoring and maintenance of the Pharmaceutical Quality System as per the schedule included. Role Specific

• Leading, guiding and support Laboratory staff, as well as developing staff to competent levels, while ensuring that self and staff behaviour are aligned with company values and expectations and where necessary, uses the company disciplinary process to correct behaviour.
• Attend and represent laboratory teams in various meetings and report back to laboratory team meetings.
• Analyse samples using specialised equipment and advanced analytical techniques.
• Applying and maintaining standards.
• Identify projects for continuous improvement.
• Ensuring high standards, accuracy and repeatability of methods.
• Commissioning new equipment.
• Procurement of laboratory consumables.
• Ensuring proper functioning of strategic equipment and that calibrations are performed timeously.
• SHE Accountability, including housekeeping.
• Monthly Quality Control reporting.
• Manage and co-ordinate stability program.
• Develop and optimize test methods (method validation/measurement systems analysis).
• Set up Gage R&R/Proficiency Testing as and when required.
• Trend and statistically analyse data pertaining to product performance characteristics.
• Review and write laboratory/testing procedures.
• Provide support with regulatory compliance, GLP and GMP, Health and Safety and Corporate standards.
• Investigate out of specification results according to QMS OOS Guidelines and solve technical problems.
• Check raw data and Approve final results submitted by Laboratory Testing Associates.
• Check and sign raw material testing results.
• Conduct internal audits where required.
• Manage monthly training schedule and report on training achieved.
• Conduct routine laboratory testing if required
• Deputizes for the Site Quality and Regulatory Leader / Management Representative (Responsible Pharmacist) in his/her absence from the office on all matters impacting on quality control.
• Supporting the Site Quality and Regulatory Leader for compliance with the provisions of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) relating to the control of the manufacturing of products.
• Supporting the Site Quality and Regulatory Leader / Management Representative (Responsible Pharmacist) for compliance to Good Practices as published by the South African Health Products Regulatory Authority.
• The person responsible for Quality Control should have the authority to establish, verify and implement all quality control procedures.
• Ensures commitment and full participation to shared or joint responsibilities with the Head of Production and Head of Quality Assurance (as stated under shared responsibility).
• It is important that both direct and shared responsibilities are understood by the various Heads.
• Ensure that written training programs are available and approved.
• Ensures that any non-conformances and/or deviation from established procedures should be documented and explained. Critical deviations should be investigated, and the investigation and its conclusions must be documented.

The head of Quality Control generally has the following responsibilities: (i) To approve or reject, as he/she sees fit, starting materials, packaging materials, intermediate, bulk and finished products;
(ii) To ensure that all necessary testing is carried out and the associated records evaluated;
(iii) To approve specifications, sampling instructions, test methods and other Quality Control procedures;
(iv) To approve and monitor any contract analysts;
(v) To ensure the qualification and maintenance of his/her department, premises and equipment;
(vi) To ensure that the appropriate validations are done;
(vii) To ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need.

• Ensure that that sufficient reference and retention samples are available for all raw materials, intermediates and final product.
• Other duties of Quality Control are summarised in Chapter 6 in the PIC/S Guide to Good Manufacturing Practice for Medicinal Products, PE 009-14-PART I (separate attachment).
• Training of new and existing staff in laboratory test methods and GLP.
• Co-ordination of laboratory samples for testing including stability samples.
• Ensuring the in-process laboratories are functioning and optimum levels.
• Purchasing of laboratory consumables and having approval to purchase up to a max of R5000.
• Signing and approving all annual and sick leave.
• Develop contingency plans when staff are off sick or take planned leave.
• Executing disciplinary protocols in the event company rules are breached.
• Checking and approving laboratory test reports.
• Scheduling of equipment maintenance and calibrations.
• Establish and qualify in-house reference standards.
• Provide solutions to specific technical challenges encountered with laboratory equipment and troubleshooting during Out of Specifications;
• Provide solutions to service demands expected from laboratory team
• Adhere to workplace policies and procedures;
• Log Out of Specification and Non-Conformances reports
• Close out Corrective Actions as per target dates and maintain compliance KPI >85%.
• Report unsafe acts and log preventive actions

Qualifications and Training
Tertiary B.Tech/ BSC qualification in Biochemistry/Chemistry/Analytical Chemistry or equivalent Knowledge and Experience

• 3 - 5yearsxe2x80x99 laboratory experience in a supervisory or leadership role.
• Behavioural coaching and performance management experience.
• Labour Relations, System knowledge (ISO13485, GMP & GLP guidelines).
• Applied statistics/Statistical Process Control, Method/computer/cleaning validation, equipment IQ/OQ/PQ.
• Theories and principles of Biochemistry/Analytical Chemistry/Chemistry.
• Laboratory Safety.
• Laboratory instrument knowledge and experience.

Key Skills Required

• Strong problem-solving capacity.
• Applied Statistics / Statistical Process Control.
• Continuous Improvement skills/knowledge of Lean Manufacturing and 5S Housekeeping.
• Intermediate computer skills - in particular MS Office
• Assertive.
• Ability to motivate, coach and develop people
• Literate in English.
• Written report skills (capacity to compose protocols, technical reports and procedures).
• Good communication and inter-personal skills on various levels.
• Strong planning and organizational skills.
• Behavioural coaching skills.
• Presentation skills.
• Strong technical and analytical skills.
• Able to set and meet objectives.
• Team orientation xe2x80x93 willingness to work with others in a team environment.
• Ability to multi-skill and multi-task.
• Adaptable to adjust effectively to work within new structures, processes, requirements, cultures.

Job Types: Full-time, Permanent