QA Operations Specialist

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:

An amazing opportunity has arisen for a QA Operations Specialist. This role will be responsible for supporting the clinical and commercials operational activities, at single use multi-product biotech facility. You will works across site teams to resolve issues and drive quality, EHS, learning, and continuous improvement, while ensuring compliance with cGMP and corporate regulations.

Requirements

What you will do:

Bring energy, knowledge, innovation and leadership to carry out the following:

• Provide QA oversight to the clinical and commercial

operations at the facility including quality control, supply chain, engineering and manufacturing and support process technical transfers, analytical technical transfers, drug substance disposition and regulatory approvals.

• Responsible for supporting execution of an effective

Quality system and accountable for quality oversight of quality management systems (CAPAs, Change Controls, Deviations Batch Documentation Review).

• Liaises with internal partners (e.g. Manufacturing

Operations, MS&T, Engineering functions etc) in support of daily operations.

• Coordinate with peer Quality groups to ensure on-time

disposition of commercial Drug Substance.

• Ensures clear communication on issues and timely

escalation as applicable.

• Helps maintain site practices and procedures related to

clinical and commercial operations.

• Responsibility for adhering to domestic and international

GMP regulations, cGMP’s, company policies, leadership behaviors, and performance and budget management.

• Champion site metrics to ensure targets are achieved, met

and counter measures in place when applicable.

• Representing Quality on multidisciplinary teams.

• Executing company policies.

• Ensures new/revised quality system requirements are

deployed to the Site.

• Ability to work on his/her own initiative in addition to

working as part of a team

• Possess strong problem solving and trouble shooting

skills

What skills you will need:

In order to excel in this role, you will more than likely have:

• Degree or post-graduate qualification in Science,

Pharmacy or equivalent.

• Minimum 3 years’ experience in the biotechnology and/or

pharmaceutical industry.

• Previous Experience with deviation management/Change

controls

• Previous Experience in Batch Record Review is preferable

• Knowledge of cGMP regulations both domestic and

international.

• Proven decision-making capability with full

accountability and responsibility.

• Ability to think logically and be proactive under

pressure.

• Ability to work as part of a team and on own initiative

in a constructive manner.

• Flexible and self-motivated.