*About PSC Biotech*
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 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 & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.
- Performs commissioning, qualification, and validation testing on utilities and manufacturing process equipment and instruments
- Authors protocols, initiates controlled documentation in support of CQV projects
- Provides project planning, management, execution, and follow up
- Reviews equipment specifications, manuals, and develops an understanding of how instruments work; tests equipment accurately to meet requirements for intended use
- Investigates failures and deviations; creates reports
- Analyses and reviews spare parts lists to ensure they are fit for purpose
- Reviews engineering drawings for accuracy and acts to correct errors
- Performs system walk-downs and makes changes using the change control of processes
- Initiates and resolves client Corrective and Preventative Actions (CAPAs)
- Provides analyses and summary reports
- Creates and maintains job plans, maintenance and PMs
- Applicable work experience in the pharmaceutical or biotechnology industry
- Experience with Mixing Tanks and CIP Skids
- Expert understanding and work habits compliant with cGMPs and pharmaceutical and biopharmaceutical unit operations
- Good understanding and application of commissioning and qualification and willingness to learn
- Good analytical, organizational, time management and problem-solving skills
- Exceptional writing skills required to author and execute DQ, FAT, SAT, CTPIQ, OQ, PQ, and PV documents, develop SOPs, create final reports and author validation and quality policies, procedures and guidelines
- A thorough and working knowledge of and ability to apply GMP, GCP, GLP, GAMP and CFR21 Part 11 guidelines to ensure compliance as they relate to qualification of systems and validation of processes
Job Types: Full-time, Contract
- Pharmaceutical/Biotech Industry: 2 years (Preferred)
- CQV: 2 years (Preferred)
- United States (Preferred)