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.
PSC Biotech is looking for a Operations Documentation Specialist.
Role Functions
- Responsibility for the timely, accurate and efficient management of documents including access and revision control.
- Manage and implement on the floor documentation control system.
- Creation and revision of Standard Operation Procedures (SOP’s), Work Instructions (WI’s) are required.
- Drive the Documentation life cycle system to ensure documents are approved in timely manner as per scheduling requirements.
- Work with SME’s and various internal and external stakeholders to ensure technical documentation updates are created and approved.
- Collaborate with QA, Supply chain and Operations core functions.
- Ensure Compliance with all regulatory GMP, Safety and Environmental Requirements.
- Report status of documents, identify areas of opportunities and action plans required.
Coordination of Quality Notifications, CAPA’s and overall Deviation management.
Manage ‘’Live’’ Documentation updates and report progress on documents
Ensure effective planning, common understanding and targets for specific documentation
- Maintains a thorough knowledge of documentation needs.
- Provide updates on a regular basis to functional directors, associate directors managers on deviation, documentation and CAPA’s.
- Identify Risks, Gaps and Opportunities related to documentation - work with Area Owners and Subject Matter Experts to ensure documentation updates are approved.
Requirements
Key Personal Skills
· Networking skills within peer and other work groups across the site.
· Enthusiastic contributor to the creation and development of our site culture.
· Exceptional communication skills and ability to communicate to multiple levels within company.
· Experience with technical writing.
General
● Experience in the Pharmaceutical GMP regulated industry desirable.
● Excellent verbal and written communication skills.
● Ability to work independently and as part of a team in a cross functional collaborative environment.
● Experience working with GMP Documentation Management Systems
● High level of attention to detail.
● Demonstrated ability to manage multiple priorities against ambitious timelines. Strong planning ability.
● Strong problem-solving skills and ability to work cross-functionally.
Technical experience
● Should be proficient with Microsoft Office tools, (MS WORD/PowerPoint/ /Microsoft)
● Experience with SAP/Trackwise/Veeva Quality docs advantageous.
Education requirements
- A minimum of level 6 qualification in a Science, Engineering, or Project Management discipline
Job Types: Full-time, Permanent
Schedule:
- Monday to Friday
Work Location: In person
