About PSC Biotech Who are we?
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.
Requirements Responsibilities: Liaise with the Automation and Validation departments in an effective and timely manner as part of generating Automated System Periodic Evaluation Program (PER Program) reports.
Responsible for generating maintenance reports as part of the Maintenance program example review and trending of work records.
Liaise with multiple departments in data review.
Collate responses in an timely and effective manner.
Facilitate reviews and revisions of Department related SOP's, life cycle documents, plans and policies for each group within the Department.
Facilitate support of preventative maintenance record review and audit trail review.
Ensure report writing deadlines are meet and data is concise and accurate and meets ALCOA+ principles.
Support department in lead up to audit in preparation of support documentation.
Support automation in administration of equipment access.
Maintains knowledge of current good manufacturing practices (cGMPs).
Skills Required: Experience working in a regulated GxP environment.
Ability to work on own initiative, without direct supervision from management.
Team player with an ability to work well across various departments on site as well as business partners.
Project management skills.
Excellent written and communication skills.
Deadline focused individual.