Metrology Analyst - Talent Pipeline

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