TELECOMMUTE – US National
Senior Validation Manager
Work Experience5+ years
Who we are?
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.
?Take your Career to a New Level’
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points which include the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/Biotech Industry. We offer a permanent contract of employment giving exposure to working in Top Pharmaceutical client sites in a diverse-cultural work setting.
Demonstrates strong knowledge of Good Manufacturing Practices (GMPs) and working knowledge of regulatory filing requirements and guidance documents.
Responsible for all validation activities across several manufacturing and laboratory locations.
Author validation plans, protocols IQ, OQ and PQ, test scripts and reports.
Execute process validation studies and data analysis and compile data and results into summary and final reports.
Work with Validation Team to develop and maintain Validation protocols.
Provide guidance to staff in preparing protocols, executing validation projects, developing approaches and strategies, alignment with internal procedures and industry best practices.
Guide and arrange process validation for new products, technical transfers, sustainability initiatives
Deliver technical input to strategies and philosophy for process validation activities
Develop, execute and document risk assessments and evaluations to determine testing strategies and requirements
Provide technical assessments on change controls, deviations and investigations
Assess proposed changes to validated processes to identify requirements necessary to maintain validated status
Participates in audit and inspection preparation and response activities. Supports interactions or interacts with regulatory agencies
Participates in client audits and regulatory inspections and audits as needed
Presents and/or defends cGMP documentation associated with quality validation practices
Establishes validation best practices, process validation strategy and maintenance and management of validation processes to be used as a guide for future projects and products.
Subject matter expert for process validation topics
Supports change controls, deviations and CAPAs relevant to process validation topics
Conducts validation workshops and provides site wide validation training as necessary
Motivates, retains and develops key employees. Develops employees and ensures adequate skill sets in accordance with Talent Management based on performance dialogue, performance evaluation and individual career development plans, including training plans
Ensures that the right skills and capabilities of people in the Validation function are developed to enable the organization to be flexible/adapt to dynamic business conditions
Maintain safe and healthy work environment by establishing, following and enforcing standards and procedures, and complying with …
Medical & Health,Pharmaceutical