What are the responsibilities and job description for the Associate Director, QA Operations position at TANVEX BIOPHARMA USA INC?
Job Description
Job Description
Description : SUMMARY
The Associate Director, QA Microbiology & Validation will be responsible for managing and leading the Validation program for Tanvex's manufacturing and testing facility. will establish validation and re-validation policies, programs and procedures for processes, equipment, software, and systems that comply with Good Manufacturing Practices and oversee the execution of new and routine validation activities. is responsible for overseeing the environmental monitoring program and testing samples for microbials throughout the manufacturing process.
JOB RESPONSIBILITIES
Essential
Validation
- Maintain all necessary Validation Plans, including strategies, work schedule / timelines, and resource planning / requirements.
- Develop and maintain / update Validation SOPs to ensure consistent application of the requirements and strategies.
- Recommend and implement improvements to Validation and associated quality systems in order to make them robust, compliant, and defendable.
- Plan, coordinate, and direct site validation activities of new, modified, and existing facilities. Manage resources to ensure timelines, budget, and milestones are met. Ensure all personnel (internal and contractors) utilized to perform validation activities have the appropriate resources, skill set and required training.
- Provide effective leadership including individual goal setting / performance reviews, managing the development of employees, recognizing and appreciating employee contributions, mitigating conflict and communication problems, planning and facilitating team activities, selecting personnel and motivating members of the functional area.
- Oversee validation efforts performed by contract service providers.
- Support development of other lifecycle documentation including user / system requirements, risk assessment, design qualification, review and approve site procedures.
- Ensure that validation data and records are properly managed and maintained.
- Work closely with Quality, Process Development, Facilities, and Production to investigate and resolve deviations through determining root cause, product impact, and appropriate corrective and preventive actions related to equipment or validated process parameters.
- Provide responses to audit observations and manage audit related CAPA commitments.
- Support validation review of investigations and change management as well as facility inspections, audits (both performed by internal groups and by regulatory agencies), regulatory submissions and annual product reviews.
Microbiology
Manage sampling of non-viable air, viable air, and viable surface samples for manufacturing clean rooms, incubations of samples and reading / interpreting / reporting of results.
o individual goal setting / performance reviews.
o motivate employees, provide coaching and feedback for individual career growth and development.
o recognize and appreciate employee contributions.
o mitigate conflict and communication problems.
o plan and facilitate team activities.
o recruit / hire personnel.
o provide training and emphasize best practices.
o recommend and present disciplinary actions to subordinates when required.
JOB REQUIREMENTS
Education and Experience
Knowledge, skills and abilities
Requirements :