Job purpose

· Manage the execution of all laboratory equipment, sourcing, qualifying, maintenance, calibration, compliance activities and adherence to specified timelines, including any deviations to work schedules

· Ensures the repair of laboratory equipment timeously according to policies and procedures

· Facilitate interaction with QC laboratory management team to ensure equipment is maintained and calibrated according to procedures, on time and available for use.

· Escalate all failures to the QC management timeously.

· Oversee contractors in the execution of activities

· Monitor contractor adherence to SLA and KPI’s

· Manage resources to execute plans and monitor schedule compliance

· Ensure safe and efficient execution of required activities

· Enforce legal compliance of maintenance operations

· Ensure tools, assets, controls are within required guidelines and standards

· Ensure stock levels are maintained to prevent out-of-stock situations (calibration standards, spare parts, etc)

· Ensure weekly routine maintenance schedule is executed as planned/scheduled

· Ensure continual compliance of laboratory standards and SOPs to latest pharmacopeial, and regulatory compliance

· Continually improve and optimize work processes

· Provide input into operational planning and prioritization of section objectives

· Provide input into budgets & resource requirements for section

· Ensure Capex management for the QC laboratory equipment is based on needs and business objectives.

· Participate in development of work schedules

· Participate in sourcing (URS/UB), purchasing, receipting DQ/IQ/OQ/PQ of all new equipment.

· Participate in all requalification activities with support functions.

· Actively Participate in Laboratory investigations and problem solving where equipment is impacted

· Ensure that all data generated are reviewed and released according to cGMP and data integrity policies and procedures

· Ensure all documentation generated is retained and easily available during audits

· Plan daily and weekly activities

· Provide coaching and supervision for technicians/analysts when required

· Manage and execute priority work orders/ jobs when necessary

· Perform maintenance/calibration/trouble shooting on all QC Laboratory Equipment

· Liaise with QC Laboratory and Engineering to ensure that the maintenance plan is accommodated

· Liaise with suppliers during trouble shooting/OOS/OOT on all laboratory equipment in attempt to find and correct root causes.

· Co-ordinate problem solving and priorities execution of tasks

· Ensure that jobs are properly completed and closed on time

· Provide input for improvement of risk-based compliance systems

· Monitor implementation and correct own and/or team compliance with the current regulations and guidelines - both local and international

Minimum qualification(s)

Required:

Diploma/Degree in Microbiology/Biochemistry/Chemistry/Engineering or equivalent

Preferred:

Recognition is given to Prior Learning and practical experience.

Experience & industry knowledge

Required:

Minimum 3–5 years of experience directly performing metrology, instrument calibration, or asset management within a pharmaceutical, biopharmaceutical, or medical device laboratory.

Experience in quality and regulatory compliance within a cGMP in Sterile/Vaccine facility

Participation in monitoring expenditures for Expense Budgets and Capex related costs

Preferred:

- Working knowledge of Pharmaceutical Manufacturing related legislation

- Experience in aseptic (sterile) manufacturing within a QC Laboratory

Key Duties & Responsibilities

Technical Competencies required to perform this aspect of the role:

· Excellent understanding and working knowledge of Pragma/CMMS and OEM systems.

· Detailed knowledge of pharmaceutical industry standards and guidelines in GMP

· Documentation Management

· Inventory Management

· Environmental, Health & Safety Management

· Statistical Trending & Data Analysis

· Metric Development & Report Writing

· Coaching & Mentoring of peers & staff

· Review & Auditing Skills

· Compliance and process driven

· Customer awareness

· Communication: Effective verbal and written communication skills for interfacing with suppliers and internal teams

· Organization: Strong capability to manage multiple tasks and prioritize according to due dates and project timelines. Excellent

· Document control

Business Management

· Shared accountability for achieving the site’s tactical plans and mitigation of any risk to the site operation including workflow, ethics, quality, finances, regulatory compliance and other material company requirements.

· Identify and continuously present key opportunities and synergies that will improve and/ or expand the operation within own and/ or other departments.

· Participate in departmental and/ or site wide projects

· Monitoring & reporting on key operations, critical numbers and key performance indicators that impacts the business’s short, medium and long term objectives.

· Participate with the site management team in proactively mitigating risks and find solutions where possible

· Effective and comprehensive costing, budgeting and expense management, taking all overlapping site activities into consideration.

Core Technical Delivery

· Ensures that the Laboratory Maintenance/calibration schedule is maintained

· Manage and execute priority work orders/ jobs when necessary

· Ensures that calibration and preventative maintenance of lab equipment is performed according to SOPs

· Ensures that faulty lab equipment is repaired within set timelines and according to policies and procedures

· Ensures OOS, OOT and OOE results are investigated according to set procedures

· Ensures all data generated are reviewed and released according to cGMP and data integrity policies

· Escalate calibration, maintenance deviations/instrument failures to Laboratory management

· Participate in development of quality job plans with Maintenance Planners

· Test effectiveness of maintenance plan

· Liaise with Laboratory management teams to ensure that the maintenance plan is accommodated

· Co-ordinate problem solving and prioritise execution of tasks

· Participate in development of work schedules

· Ensure weekly routine maintenance schedule is executed as planned/scheduled

· Monitor and track progress of all open requisitions

· Review work order for completeness and sign off work requisition feedback

· Ensure that jobs are properly completed and closed on time

· Oversee contractors in the execution of maintenance/calibration activities

· Monitor contractor adherence to SLAs and KPIs

· Ensure tools and assets are maintained within standards

· Ensure all new equipment is qualified according to the set procedures

· Ensure that all maintenance related records are maintained and are easily retrievable

· SME with regards to laboratory maintenance in regulatory audits.

Quality Management

· Building own, team and site’s GMP Knowledge and Compliance

· Participate in building quality objectives and provide ongoing metrics that directly support the achievement of such objectives.

· Participate in building a sustainable Quality Culture on site and proactive mitigate risks that may negatively impact quality or escalate these appropriately.

· Establish and maintain a state of control related to quality management within the department

· Ensuring that the department is audit ready through closing out audit findings timeously

· Ensure Deviations, Change Controls, CAPAs are handled effectively

· Advocate continuous improvement within own department as well as cross functionally

Technical Competencies required to perform this aspect of the role:

· cGMP vaccine manufacturing- quality and regulatory compliance knowledge, i.e. MCC and WHO

· Advanced knowledge of methods, practices, techniques and equipment used in laboratory, maintenance and repair

· Working Knowledge of laboratory processes, procedures and maintenance activities

· Knowledge of pharmaceutical manufacturing, standards and compliance requirements

· Ability to interpret and implement policies, processes and objectives