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. We serve 350 clients in more than 23 countries worldwide. Our services include cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services.
‘Take your Career to a new Level’
PSC Biotech disrupts the conventional consultancy model by offering a unique Employee Value Proposition (EVP), providing opportunities to work with talented professionals in the Pharma/Biotech industry. We offer permanent contracts, exposure to top pharmaceutical client sites, and a diverse, multicultural work environment.
Employee Value Proposition
Employees are the heartbeat of PSC Biotech. We provide empowering career development through in-house training, mentorship, and continuous guidance to facilitate career progression. We aim to create high-performing teams that exceed client expectations in quality, stay within budget, and meet deadlines.
Overview
The Quality Assurance Specialist role involves:
1. Working a 4-shift pattern role.
2. Applying technical knowledge of sterile manufacturing processes.
3. Performing timely reviews of batch documentation, investigations, and reports, highlighting concerns and assisting in resolutions based on risk.
4. Responding swiftly to unplanned events and technical issues.
5. Operational experience with quality systems like SAP, Trackwise, MES in a dynamic manufacturing environment.
6. Understanding of relevant quality and compliance regulations, including cGMP, US, and EU regulatory standards.
7. Conducting and reporting quality metrics to ensure audit readiness and cGMP compliance.
8. Supporting spot checks and walk-throughs of production lines.
9. Participating in customer complaint investigations if required.
10. Supporting annual product quality reviews as needed.
Requirements
Responsibilities:
1. Providing quality support to IPT production teams to maintain cGMP standards.
2. Preferably understanding sterile manufacturing operations.
3. Learning and utilizing computerized systems for daily tasks.
4. Prioritizing and managing multiple tasks to meet deadlines.
5. Reviewing batch documentation (EBRs), line clearances, and assisting with concern resolutions, liaising with other departments to improve GMP and quality standards.
6. Staying updated on regulatory developments related to quality compliance.
7. Adhering to manufacturing, quality, and EHS management system requirements.
8. Promoting continuous improvement using Six Sigma tools and supporting operational improvements from the start.
Reporting Structure: Quality Assurance IPT Manager
Qualifications, Skills & Experience
Technical:
* Experience with sterile filling processes, equipment, and support services.
* Lean Six Sigma methodology experience is desirable.
Education:
* Degree in Science, Engineering, or Technical field, or equivalent experience.
* Experience in sterile manufacturing.
General Skills:
* Good organizational skills and attention to detail.
* Effective written, verbal, and interpersonal communication skills.
* Ability to learn and utilize computerized systems.
* Strong influencing skills.
* Analytical and systematic problem-solving abilities.
People Skills:
* Focus on customers and patients.
* Ability to collaborate.
* Act with candor and courage.
* Make rapid, disciplined decisions.
* Drive results.
* Demonstrate ethics and integrity.
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