Operations Technical Specialist

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 cloudbased 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 likeminded 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 diversecultural work setting.

Employee Value Proposition

Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse 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 crossfunctional problemsolving 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 crossfunctional project teams.

Adherence to highest standards for Compliance (Quality and Safety).

Ensure compliance with site EHS policy cGMP and other business regulations and lead/coordinate 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:

13 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.