Validation Team Leader (Port Elizabeth) at Aspen Pharma Group

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