QA Operations specialist-Shift

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

Job Purpose

• This role will be part of our QA Operations Self Directed

Work Team (SDWT) in our state of the art single use multi-product biotech facility

• The QA Operations Specialist role involves supporting the

operational activities, technical transfers, regulatory approvals and commercial operations at the single use multi-product biotech facility.

• The QA Operations Specialist will work across the site

self-directed work teams and hub teams to identify and resolve issues in order to allow the site to deliver on our commit culture that support Quality, EHS, Learning and Continuous improvement.

• The QA Operations Specialist will be responsible for

supporting the Operations team, ensuring compliance with cGMP and corporate regulations.

• 11 months of maternity cover

Requirements

Key accountabilities:

• Reviews and approves batch records, discrepancy

reporting, investigations and CAPAs associated with all areas of Manufacturing operations.

• Liaises with internal partners (e.g. Manufacturing

Operations, Process development Technical services (PD-TS), Engineering functions etc) in support of daily operations.

• 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).

• Coordinate with peer Quality groups to ensure on-time

disposition of commercial Drug Substance.

• Ensures clear communication on issues and timely

escalation as applicable.

• Provide QA oversight to the qualification/validation,

technical transfers, regulatory approvals and commercial operations at the facility.

• Review/Approval of validation/Qualification/verification

protocols and reports associated with new product or material entry.

• Helps maintain site practices and procedures related to

facility start-up, instrument qualification, usage, technology transfer execution, and commercial manufacturing.

• Responsibility for adhering to domestic and international

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

• Provide support and expertise for the preparation of

regulatory submissions, inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, and monitoring of follow up actions.

• 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.

Education and experience requirements:

• Degree or post-graduate qualification in Science,

Pharmacy or equivalent.

• 4+ years experience in QA.

• Demonstrated knowledge of Quality Management System

tools, continuous improvement methodologies & in-depth understanding of site level products & related processes.

• Demonstrated expertise to effectively communicate within

all levels of the organization around concepts of design controls, design verification and validation activities; production & process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.

• Demonstrated collaboration, negotiation & conflict

resolution skills.

• Excellent communication skills (written and oral).

• Must be able to work across a team matrix in order to meet

accelerated timelines.

• Demonstrated understanding of continuous quality /

process improvement tools (As defined by the site, e.g. DMAIC, Lean QA, 5S etc).

• Experience in performing internal audits and

participating in external audits.

• Exceptional analytical, problem solving & root-cause

analysis skills.

• Ability to multi-task and handle tasks with competing

priorities effectively.

• Strong technical aptitude (i.e. able to read &

comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.

• Experience with working in a multinational organisation.

• Strong operations support background ensuring value added

and effective quality oversight

Shift pattern 16/7:

• 16 = The workplace operates for 16 hours per day.

• 7 = The workplace operates all 7 days of the week,

including weekends.

• Working hours: 7:00 AM to 11:00 PM.

• 6 Shift Cycle: The roster uses six shift/team codes (A,

B, C, D, E and F) and combinations of these codes.