3 weeks ago
Job title : Validation Team Leader (Port Elizabeth)
Job Location : Eastern Cape, Port Elizabeth
Deadline : October 24, 2024
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Description
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 re-qualification of equipment and utilities as appropriate as per Protocol.
- Prepare and perform re-qualification of equipment and utilities as per SOP.
Governance, Risk and Compliance
- Review accuracy and integrity of protocols, reports and documentation generated comply with regulation.
- Review compliance of validation documentation with QMS
- 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
- Hold a degree or equivalent qualification in Science (Chemistry, Microbiology) or Engineering (Chemical, Pharmaceutical or Process), or equivalent industry experience
- Supervisory/ Management experience
- Experience in validation techniques, and computer related systems qualification
- Experience in validation of secondary processes associated with filling lines and isolators such as
- Vaporised Hydrogen Peroxide (VHP), Clean in Place (CIP), Steam Sterilisation in Place (SIP), Aseptic
- Process Simulations and Process Performance Qualification (PPQ)
Specific job skills
- Comprehensive knowledge in the application of Qualification and Validation principles pertaining to aseptically filled products
- 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
- Technical writing skills
How to Apply for this Offer
Interested and Qualified candidates should Click here to Apply Now
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