The Validation Manager is responsible for ensuring compliance with FDA/EU and other regulatory requirements pertaining to the facility, utilities, processes, computer systems and equipment at Sanaria. This role will be responsible for supervising the validation team and providing support for audits, regulatory meetings, design activities, facility start-up activities, URS/FRS, FAT/SAT, technical transfers, cycle development re-qualifications and routine activities as they pertain to Sanaria’s QA and GMP manufacturing activities.
- Ensure facility and systems are compliance with Sanaria’s Validation Program.
- Acts as the subject matter expert for validation. Manages the validation program by ensuring validation, periodic review, and requalification of equipment, processes, and systems.
- Review and provide guidance to equipment/facility qualification, computer systems, cleaning validation, process validation, IQ/OQ/PQ protocols and reports and associated change control systems
- Manage and provide guidance to the validation team. Proactive in developing the technical skill-set of the team members through training, coaching, with the goal of professional growth, improved job performance and career satisfaction at Sanaria.
- Review, revise, and harmonize SOPs to ensure compliance with internal processes and regulatory requirements.
- Assisting other departments by providing feedback from a validation compliance perspective as it relates to new/legacy equipment, processes, systems.
- Understand and apply risk-based methodologies for QA, GMP manufacturing, and validation activities.
- Participates in continuous improvement efforts at Sanaria through the evaluation of system trends, performance indicators, audit and stakeholder/senior management feedback, and corrective/preventative actions.
- Support regulatory inspections by FDA, EMA and foreign regulatory agencies.
- Work with the Facilities and Manufacturing groups to review designs, develop and execute FAT/SAT/Tech Transfer plans.
- Provide support to the initiation, assessment and implementation of change controls.
- Provide quality oversight and support for process, cleaning, shipping, computer system, equipment and instrument qualification and validation activities.
- Manage and work within approved budgets while building best in class quality processes and systems at Sanaria.
- Manage the validation system from a QA perspective to ensure quality and compliance requirements are met in an efficient and effective manner, and in support of corporate objectives.
- Participates in presentations to senior management and regulatory agencies regarding the status of validation at Sanaria.
Education and Experience
- A minimum of a Bachelor’s degree in Science or Engineering or associated fields is required.
- A minimum of ten (10) years experience in Validation, Quality Assurance, Facilities Engineering, in the Pharmaceutical, Biotech, medical device industry (or related industry), or experience in related engineering areas, e.g. R&D or Manufacturing.
- Advanced degrees may be used to reduce required experience
Knowledge & Skills
- Extensive knowledge of quality tools:
- Validations and Qualifications
- Regulatory guidelines
- US Pharmacopoeias
- Internal auditingHandling of regulatory Inspections
- Well versed with Change control/deviations and market compliant management system.
- Strong understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Documentation Practices (QDP); and ICH Q8, Q8, and Q10 procedures.
- Understanding of regulations FDA, EU, ICH, ISO, etc.
- Certified Lean Six Sigma Green Belt or Black Belt and/or Certified Quality Engineer (CQE), strongly desired.
- Proficiency with Microsoft Word, Microsoft Excel, and Power Point is required. Strong documentation skills are required.
- Strong interpersonal and communications skills are required.
- Experience with using validation equipment: Kaye, Veriteq, TCs, Dataloggers, etc.
- Adept with using new technology and able to self-learn.
- The ability to work independently, or within a team structure, and on multiple projects, with flexibility to adapt to changing priorities is required.
- This candidate must be a technical expert and have excellent written and oral communication and interpersonal relationship skills.
- Experienced in participating in audits.