QA Operations Specialist-Shift

Overview

QA Operations Specialist-Shift role at PSC Biotech Corporation

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About PSC Biotech

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.

Employee Value Proposition

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 like-minded professionals operating in the Pharma/Biotech Industry. We offer a permanent contract of employment giving exposure to working in Top Pharmaceutical client sites in a diverse-cultural work setting. Employees are the "heartbeat" of PSC Biotech; we provide empowering career development through Learning & Development, in-house training mentorship, and guidance to facilitate career progression. We aim to create high performing teams that exceed client expectations in quality, stay under budget, and ensure timelines are met.

Overview (Quality Operations)

The Quality Specialist provides direct Quality support to a production area as part of a Quality IPT (Integrated Product Team). With guidance from the Associate Director of Quality Operations, the Quality Specialist ensures quality and compliance of products manufactured by the functional area, adherence to cGMP and Documentation Practices, and represents quality on the shop floor. The Quality Specialist performs reviews of process documentation/data for accuracy, completeness, and data integrity compliance. The incumbent may support the completion of batch disposition activities for release of product and may assist in conducting investigations of deviations. Additionally, the Quality Specialist spends significant time on the shop floor in a team environment to provide quality coaching and guidance, to enable documentation to be completed right first time, and to ensure compliance with cGMPs and regulatory requirements.

Shift Pattern: This is a shift role (4 x 12hr extended days followed by 4 days off)

Responsibilities

• Review/approve new and updated Master Batch Records / Electronic Batch Records
• Review and approve production documentation such as executed electronic batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures
• Provide presence on the shop floor to support compliance and data integrity
• Review and approve new and updated SOPs/Work Instructions and Controlled Job Aides
• Actively participate in the Tier process and use this forum to make issues visible and partner with the functional area on resolution
• QA support, review and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment
• Serve as the Quality SME for Performance qualification (PQ) activities across the site including but not limited to: Equipment, Facility and Utility PQ studies, Cleaning Validation, SIP, process validation
• Participate as the quality member on cross functional projects
• Support sustaining activities such as Change Management, Deviations, CAPAs, Equipment Requalification and Periodic review, Site Maintenance & Calibration Program
• Provide support to internal audits and regulatory inspections
• Collaborate with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans
• Drive continuous improvement and utilise problem solving tools and participate in continuous improvement initiatives to enhance operational efficiency and resolve issues

Experience, Knowledge & Skills

• Minimum 5 years of relevant post-degree work experience in GMP Manufacturing, Quality Assurance or Laboratory environment, Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or laboratory operations
• Seasoned professional with at least 5 years in the biotech industry with QA operations and regulatory engagement experience
• Evidence of leadership skills coupled with good oral and written communication skills
• Understanding of cGMPs and regulatory requirements as they apply to the pharmaceutical field or a related area
• Interpersonal skills including flexibility, collaboration and inclusion and ability to work in a team environment

Preferred

• Quality systems, pharmaceutical manufacturing or laboratory processes, authoring and approving GMP documents
• Analytical aptitude, critical thinking, and problem-solving skills
• Ability to upskill/coach others
• Experience working on manufacturing shop floor
• Familiarity with GMP documentation review and/or shop floor auditing

Qualifications & Education

• Bachelor degree in a scientific or engineering field (preferred); candidates with degrees in other fields will be considered if accompanied by significant relevant experience

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Quality Assurance

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