Job Description
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.
Overview:
* Responsible for supporting the Quality Control Department in the management of laboratory GMP documentation, and in supporting the various administrative duties. Ensuring that objectives are effectively achieved to, consistent with client’s requirements to ensure Compliance, safety and reliable supply to our customers.
* This is a day role, Mon-Friday based on site.
Requirements
Role Functions:
* Be a document system expert for the Quality Control Department; this will include document generation and review and document system work-flow expedition where applicable - examples include Standard Operation Procedures, Work Instruction, Policies, Safety procedures, Annual Product Reviews, electronic logs.
* Format, write and deliver necessary documentation in line with client’s Global Policies, Procedures and Guidelines, regulatory requirements.
* Support laboratory administration activities through documentation generation, documentation filing, tracking and auditing.
* Manage and complete department specific assignments, including periodic review of documents.
* Support continuous improvement by active participation and engagement with laboratory team for document updates out of investigations and corrective actions.
* Contribution to Kaizen events and documentation improvement projects as appropriate.
* Ensure timely completion of all assigned documents to meet site metric requirements.
* Work collaboratively to drive a safe and compliant culture
* Participate in QC daily meetings and ensure effective communication of assigned tasks/projects etc.
* May be required to perform other duties as assigned.
Experience, Knowledge & Skills
Technical:
* Proficiency in Microsoft word, Office, excel and electronic data management systems
* Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
* Report, standards, policy writing skills required
* Understanding of Lean Six Sigma Methodology preferred
Business:
* Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers, in a team orientated manner
* Ability to work with teams and escalate issues to management in a proactive manner
* Customer service
* Goal/results orientated
* Training skills
* Effective time management and multi-tasking skills
* Proven organizational skills
* Excellent attention to detail
* Self-motivated
* Flexible approach
* Planning and scheduling skills
Qualifications & Education
* Typical Minimum Education:
* Degree preferred; ideally in a related discipline
Typical Minimum Experience:
* Experience and/or a particular skill set in their area of expertise that adds value to the Business, preferably GMP setting.
Requirements
Responsible for supporting the Quality Control Department in the management of laboratory GMP documentation, and in supporting the various administrative duties. Ensuring that objectives are effectively achieved to, consistent with client’s requirements to ensure Compliance, safety and reliable supply to our customers. This is a day role, Mon-Friday based on site.