Operations Technical Specialist
1 month 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.
A fantastic opportunity has arisen for an Operations Technical Specialist . The Operations Technical Specialist will provide process technical support to the Vaccines IPT team, and the role will be reporting to the Vaccines IPT Operations Manager.
Requirements
Bring energy, knowledge, innovation to carry out the following:
· Support the process including trouble shooting and leading SPS for issues that occur on the shop floor.
· Managing EHS and Quality investigations and overseeing batch record reviews.
· Provide technical support to Operation functions and changes.
· Lead cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT.
· Technical Report and investigation writing.
· Be responsible for the completion of continuous improvement projects to support manufacturing operations through the development of validation schedules, master plans and validation protocols.
· Be responsible for management and completion of Batch Record reviews
· Apply Lean Six Sigma and Lean methodologies.
· Represent the department on cross-functional project teams.
· Adherence to highest standards for Compliance (Quality and Safety).
· Ensure compliance with site EHS policy, cGMP and other business regulations and lead/co-ordinate Technical IPT input to risk assessments, audits, regulatory inspections and incident investigations.
· Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.
What skills you will need:
In order to excel in this role, you will more than likely have:
· 1-3 years’ experience as an operation role in a pharmaceutical or a highly regulated environment.
· B.Sc. Degree or other qualification in Biochemistry, Microbiology, Chemistry, Engineering or a related field.
· A working knowledge of the GxP systems associated with this role would be advantageous. These include, but are not limited to: GLIMS, eVAL, Delta V.
· Experience in Batch Record reviews.
#LI-EL1
Requirements
Bring energy, knowledge, innovation to carry out the following: · Support the process including trouble shooting and leading SPS for issues that occur on the shop floor. · Managing EHS and Quality investigations and overseeing batch record reviews. · Provide technical support to Operation functions and changes. · Lead cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT. · Technical Report and investigation writing. · Be responsible for the completion of continuous improvement projects to support manufacturing operations through the development of validation schedules, master plans and validation protocols. · Be responsible for management and completion of Batch Record reviews · Apply Lean Six Sigma and Lean methodologies. · Represent the department on cross-functional project teams. · Adherence to highest standards for Compliance (Quality and Safety). · Ensure compliance with site EHS policy, cGMP and other business regulations and lead/co-ordinate Technical IPT input to risk assessments, audits, regulatory inspections and incident investigations. · Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant. What skills you will need: In order to excel in this role, you will more than likely have: · 1-3 years’ experience as an operation role in a pharmaceutical or a highly regulated environment. · B.Sc. Degree or other qualification in Biochemistry, Microbiology, Chemistry, Engineering or a related field. · A working knowledge of the GxP systems associated with this role would be advantageous. These include, but are not limited to: GLIMS, eVAL, Delta V. · Experience in Batch Record reviews. #LI-EL1
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