Csv
1 week ago
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.
Key Responsibilities:
- Provide QA oversight of qualification/ CSV documents required for successful completion of the facility start-up (Biotech facility)
- Review and approve the validation life-cycle documents pertaining to computerized system validation during the commissioning and qualification phase e.g., pre and post-execution commissioning/qualification plans and test specifications, validation summary reports & etc.
- Review and approve the engineering change control to evaluate the validation/quality impact(s).
- Support in the resolution of validation deviations and approval.
- Participate in the daily qualification coordination meeting to ensure correct event sequence in compliance.
- Support in reviewing the operational SOPs.
- Review and pre/post execution approval of validation life-cycle documents for IT systems (e.g., SAP). Ensure the systems are fully qualified/ validated and released for GMP and support in the resolution of validation deviations and approval.
- Familiar with Emerson Delta-V and Siemen PLC, or MES or LIMS knowledge.
**Job Type**: Contract
Contract length: 6 months
Schedule:
- Monday to Friday
Work Location: In person
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