Job Description
About PSC Biotech
PSC Biotech is a leading Biotech consultancy founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US. We serve over 350 clients across more than 23 countries, providing cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceutical contract manufacturing, and metrology services.
Our Unique Proposition
We offer a permanent employment contract, providing exposure to top pharmaceutical clients in diverse cultural settings. Our employee value proposition emphasizes career development through ongoing training and mentorship, fostering high-performing teams that exceed client expectations while meeting quality, budget, and timeline requirements.
Overview
The Quality Assurance Specialist will:
1. Work a 4-shift pattern role.
2. Have technical knowledge of sterile manufacturing processes.
3. Perform timely reviews of batch documentation, investigations, and reports, highlighting and assisting in the resolution of concerns based on risk.
4. Respond swiftly to unplanned events and technical issues.
5. Utilize operational quality systems such as SAP, Trackwise, and MES in a dynamic manufacturing environment.
6. Understand relevant quality and compliance regulations, including cGMP and US/EU regulatory requirements.
7. Conduct and report on quality metrics to ensure audit readiness and cGMP compliance.
8. Support the spot check and walk-through processes of production lines.
9. Participate in customer complaint investigations if required.
10. Assist in the preparation of annual product quality reviews.
Requirements
Responsibilities
- Provide quality support to IPT production teams to ensure cGMP standards are maintained.
- Preferably have understanding of sterile manufacturing operations.
- Learn and utilize computerized systems for daily tasks.
- Prioritize, manage multiple tasks, and meet deadlines.
- Review batch documentation, line clearances, and assist in concern resolution, liaising with other departments to improve GMP and quality standards.
- Stay updated on regulatory developments related to quality compliance.
- Adhere to manufacturing, quality, and EHS management systems relevant to operations.
- Support continuous improvement initiatives using Six Sigma tools and support the implementation of operational model areas.
Reporting Structure: Quality Assurance IPT Manager
Qualifications, Skills & Experience
Technical
- Experience with sterile filling processes, equipment, and support services.
Education
- Degree in Science, Engineering, or Technical field or equivalent.
- Experience in sterile manufacturing.
General Skills
- Strong organizational skills and attention to detail.
- Excellent written, verbal, and interpersonal communication skills for cross-functional interaction.
- Ability to learn and operate computerized systems effectively.
- Analytical and systematic problem-solving skills.
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