QA Operations Specialist

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 description QA Operations specialist

Job purpose:

This role will be part of our QA Operations Self Directed Work Team (SDWT) in our stateoftheart single use multiproduct biotech facility County Meath Ireland.

The QA Operations Specialist role involves supporting the operational activities technical transfers regulatory approvals and commercial operations at the single use multiproduct biotech facility.

The QA Operations Specialist will work across the site selfdirected work teams and hub teams to identify and resolve issues 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.

Requirements

Key accountabilities:

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 startup instrument qualification usage technology transfer execution and commercial manufacturing.

Responsibility for adhering to domestic and international GMP regulations cGMP s company policies leadership behaviours and performance and budget management.

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).

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 (PDTS) Engineering functions etc) in support of daily operations.

Coordinate with peer Quality groups to ensure ontime disposition of commercial Drug Substance.

Ensures clear communication on issues and timely escalation as applicable.

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.

Ability to work on his/her own initiative in addition to working as part of a team and must be open to 24/7 shift work. Must be able to work across a team matrix to meet accelerated timelines.

Education and experience requirements:

Degree or postgraduate qualification in Science Pharmacy or equivalent.

4 years experience in QA.

Demonstrated knowledge of Quality Management System tools continuous improvement methodologies & indepth 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).

Required to work on his/her own initiative in addition to working as part of a team and must be open to shift work (including 24/7 shift pattern). Must be able to work across a team matrix 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 & rootcause analysis skills.

Ability to multitask 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

#LIEL1

Key accountabilities: 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 behaviours, and performance and budget management. 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). 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. 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 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. Ability to work on his/her own initiative in addition to working as part of a team and must be open to 24/7 shift work. Must be able to work across a team matrix to meet accelerated timelines. 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). Required to work on his/her own initiative in addition to working as part of a team and must be open to shift work (including 24/7 shift pattern). Must be able to work across a team matrix 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 #LI-EL1