Job Description

• 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

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.

Skills requiredBackground/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
• Masters degree - Advantageous
• 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

Aspen Pharmacare