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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 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 points 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.
Job Title: Plant Technical QA Specialist
The Plant Technical Quality Assurance (PTQA) Specialist is a senior position within the QA function which will typically report to a QA Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility.
Key Responsibilities:
Act as Quality point of contact and decision maker during New Product Introductions Technology Transfer and Process Validation activities for Aseptic products ensuring that all activities meet client and regulatory expectations.
Quality review and approval of Process Development and Validation documentation
Technical transfer documents
Validation Protocols executed validation documents and reports.
Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
Perform all activities in compliance with client safety standards and SOPs.
In line with business requirements these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role.
Preferred Qualifications:
University degree. Science or engineering related discipline preferred.
Understanding of principles of Validation and New Product Introduction
Experience in aseptic manufacturing.
Relevant experience (7yrs ) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas (i.e. Process Development Validation Manufacturing)
Experience in change control nonconformance corrective and preventative actions and validation practices.
Ability to operate across functional boundaries both internal and external.
Ability to work independently and remotely with minimum direct supervision.
Critical thinking skills.
Strong organisational communication coordination and meeting facilitation skills.
Independent selfmotivated organized able to multitask in project environments and skilled in communication and collaboration.
Team player prepared to work in and embrace a teambased culture that relies on collaboration for effective decisionmaking.
Full Time