Candidate will be responsible to provide the vision and implementation policies for each product development according to the global authorities safety and environmental regulatory guidelines and facilitate the timely delivery of the products to the customers. The incumbent should have the professional competency to suggest, review and approve specific activities to follow appropriate biosafety and bio-containment procedures as per national and international regulatory guidelines. He/She will be responsible to address and implement a plan to solve any regulatory affairs related issue.
Develop, implement, and coordinate a comprehensive biological safety program, bio-risk management policy and manual for the plant to enhance institutional biosafety-related objectives and to ensure compliance with all applicable regulations, guidelines, policies, and directives.
Assist in developing standard operating procedures for all research work involving pathogenic agents prior to the implementation of the activity and review the procedures.
Coordinate biosafety and monitor the delivery of biosafety education and training to the staff who will be directly or indirectly working with biological pathogenic agents.
Monitor activities involving the use of hazardous biological materials in compliance with appropriate regulations, policies, procedures, and best practices.
Guide and collaborate with respective departments in designing the facility for containment as well as handling of Polio virus in Polio Essential Facility as per GAP III requirement.
Undertake necessary risk assessment analysis and its mitigation with respect to entire operation in the Poliovirus containment facility
Provide appropriate resources to ensure the adequate provision of personnel, facilities and other resources deemed necessary for containment of poliovirus as well as the safe and secure operation of the facility.
Ensure promotion of the bio-risk management system throughout the organization; establish appropriate procedures for import/export of pathogenic material to/from laboratory according to national/international regulations.
Set up the review, audit and reporting measures to provide assurance that the requirements of these standards are being implemented and maintained effectively from time to time.
Lead the team in facilitating the successful audits by NAC & WHO or other regulatory agencies for obtaining containment certifications.
Inspect manufacturing & research facilities for compliance with regulations and guidelines pertaining to the use, handling, and disposal of potential biohazards; coordinate the review and investigation of all biosafety accidents and develops corrective action plans.