Aspen ikhangela i Validation Team Leader, eMonti, eMpuma Koloni.
#EkhayaIspan 💯
Aspen ikhangela i Validation Team Leader, eMonti, eMpuma Koloni.
OVERVIEW
Facilitate and supervise validation exercises
Provide technical support, process control and process improvement activities to support validation activities.
Assist with validation activities.
Performance management of direct reports
RESPONSIBILITIES
Planning and Section Management
Execute and implement policies and procedures.
Provide input into budget and resource requirements for section.
Provide staff with day-to-day direction and tasks.
Support Validation Officers through training, facilitating and problem-solving activities.
Validation
Develop, implement, and review validation plans, SOPs and protocols to ensure continued compliance at all times.
Coordinate validation activities with QC and Production
Oversee the completion of validation activities according to validation plans/ schedule.
Evaluate risk from executed validation protocols.
Investigate deviations from validation protocols, identify root causes, and develop and implement CAPA plans.
Assist with review of re validation plans.
Maintain and audit compliance of validation activities.
Ensure test equipment is maintained and calibrated as per approved schedule and documented.
QUALIFICATION
Coordinate qualification activities with QC and Production
Compile, implement and perform the relevant qualification protocols as per SOP.
Participate in change control assessments to ensure compliant status.
of affected equipment is not compromised
Ensure documents and procedures to operate and maintain equipment are in place.
REQUALIFICATION
Assess and recommend requalification of equipment and utilities as appropriate as per Protocol.
Prepare and perform requalification of equipment and utilities as per SOP
Governance, Risk and Compliance
Review compliance of validation documentation with QMS
Review accuracy and integrity of protocols, reports and documentation generated comply with regulation.
Generate validation reports on a weekly/ monthly basis.
Monitor implementation and correct own and/or team compliance with legislation, policies and procedures.
Participate in internal and external audits.
REQUIREMENTS
Skills required.
Background/experience
Certification/ Diploma and a minimum of 5 years of related experience
Supervisory/ Management experience
Experience in validation techniques and computer related systems qualification
SPECIFIC JOB SKILLS
Comprehensive knowledge in the application of Qualification and Validation principles
Knowledge of control and instrumentation systems, electrical systems and reading of electrical diagrams
Understanding of pharmaceutical manufacturing and corrective action programs
Pharmaceutical standards and compliance requirements
Ability to interpret and implement policies, processes, and objectives.
Competencies
Interpreting and internalising information
Planning and organising
Meeting deadlines
Taking action
Working in teams
Closing Date 16 January 2024
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