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.
‘Take your Career to a new Level’
PSC Biotech disrupts the conventional consultancy model by aligning our Employee Value Proposition (EVP) as a key differentiator. We offer the opportunity to work with a talented cohort of professionals in the Pharma/Biotech industry. We provide a permanent employment contract, offering exposure to top pharmaceutical client sites in diverse cultural settings.
Employee Value Proposition
Employees are the heartbeat of PSC Biotech. We support career development through in-house training, mentorship, and continuous guidance to facilitate growth. Our goal is to create high-performing teams that exceed client expectations in quality, stay within budget, and meet deadlines.
Overview
The QA Operations role will lead Quality Assurance activities at the Research & Development Division. The role is crucial for maintaining operational compliance aligned with cGMP regulations, ensuring the site adheres to policies and regulations including FDA/EMEA standards. The ideal candidate will have relevant educational background and experience in a regulated environment, providing quality support, training, and guidance on GMP compliance and regulatory requirements.
Hybrid Role
Hybrid working is required with a minimum of 3 days per week on-site.
Requirements
Responsibilities:
1. Lead and participate in cross-functional teams to address compliance issues and meet project milestones.
2. Participate in investigations and risk assessments related to deviations, complaints, and changes, ensuring timely actions.
3. Review and approve Change Controls, Deviations/CAPAs, SOPs, and related documents for GMP compliance.
4. Oversee qualification/validation, technical transfers, regulatory approvals, and operations at the facility.
5. Handle product disposition tasks, including material release and review of eBRs prior to QP release.
6. Evaluate new regulatory guidance and industry best practices, updating quality systems accordingly.
7. Develop training curricula and records for the QA team, providing SME training as needed.
8. Create and maintain QA policies and SOPs in line with site requirements.
9. Support continuous improvement initiatives to enhance quality and efficiency.
10. Participate in risk management activities and internal audits.
11. Foster strong management and team relationships to promote a safe, compliant culture.
12. Escalate compliance risks to management promptly.
Educational and Experience Requirements:
1. Degree in Science, Quality, or Technical field.
2. 8-10 years’ experience in QA, QC, or Technical Operations within the biologics/pharmaceutical industry.
3. Project management skills with a strong understanding of operations.
4. Experience with QRM, investigations, and problem-solving as a QA SME.
5. Excellent communication skills.
6. Proactive and logical thinking under pressure.
7. Ability to work independently and as part of a team.
8. Attention to detail in GMP documentation.
9. Experience with quality management systems like Veeva, SAP, PAS-X.
10. Knowledge of regulations from FDA, HPRA, EMEA, and experience with regulatory inspections.
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