Senior Plant Quality Assurance
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Job Description
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 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.
Job Title: Senior Plant Quality Assurance
The Plant Technical Quality Assurance (PTQA) Specialist is a senior position within the QA function which will typically report to QA Snr Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility.
Requirements
Key Responsibilities:
Quality point of contact and decision maker for Plant Deviations CAPA s and EV s ensuring that all activities meet client and regulatory expectations.
Quality point of contact and decision maker for Plant Change Controls ensuring that all activities meet client and regulatory expectations.
Quality point of contact and decision maker for Process improvement projects including review and approval of Validation Protocols executed validation documents and reports.
Quality point of contact for APR s
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.
Experience in change control Deviation corrective and preventative actions (CAPA s) CAPA Effectiveness verification and validation practices.
Experience in aseptic manufacturing is preferred.
Relevant experience (7yrs ) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for Manufacturing.
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.
Key Responsibilities: Quality point of contact and decision maker for Plant Deviations, CAPA s and EV s, ensuring that all activities meet client and regulatory expectations. Quality point of contact and decision maker for Plant Change Controls, ensuring that all activities meet client and regulatory expectations. Quality point of contact and decision maker for Process improvement projects including review and approval of Validation Protocols, executed validation documents and reports. Quality point of contact for APR s 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. Experience in change control, Deviation, corrective and preventative actions (CAPA s), CAPA Effectiveness verification, and validation practices. Experience in aseptic manufacturing is preferred. Relevant experience (7yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for Manufacturing. 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, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration. Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
Employment Type
Full Time
