About PSC Biotech Who are we?
PSC Biotech is a leading Biotech Consultancy firm founded in ****, 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 point which includes 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 of working in Top Pharmaceutical client sites in a diverse-cultural work setting.
Employee Value Proposition Employees are the "heartbeat" of PSC Biotech, we provide unparalleled empowering career development though Learning fumes or airborne particles; toxic or caustic chemicals; high pressure and temperature utility systems, risk of electrical shock and vibration.
The noise level in the work environment is usually moderate.
The ability to perform gowning activities and enter the manufacturing plant is preferred, but not required.
Equipment: This position requires ability to utilize a computer to perform tasks.
Contacts: This position will require interaction with multiple levels (from technicians up through Sr. Management) in Quality Assurance, Quality Control, Corporate Compliance, Manufacturing,Technical Development, Facilities, Regulatory Affairs, and People Resources.
Scope: The candidate will have a significant role in the approval of documentation and support for release of manufacturing systems and processes for cGMP use.
This position is required to successfully complete projects in a timely manner supporting company goals and objectives.
Decisions made by this position can significantly affect project timelines and the ability to manufacture drug substance/drug product meeting Health Authority requirements.
Supervisor Responsibility: Position has no direct reports.
Career Development: Demonstrated proficiency and experience in developing and maintaining validation department within cGMP expectations for the manufacture of drugs.
Demonstrated proficiency and experience in maintaining and defending validation systems satisfying regulatory inspection scrutiny Demonstrated proficiency and experience in managing projects requiring multi-departmental coordination.
Demonstrated experience and knowledge of multi-departmental functions and issues (understanding the organization).
Successfully achieving project goals and meeting company deadlines in timely and cost-effective manner.