Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Roles & Responsibilities:
- Ensure compliance with GMP, GLP, and GDP requirements across manufacturing and quality operations.
- Review and approve SOPs, protocols, batch records, and other controlled quality documents.
- Lead and support deviation investigations, CAPA activities, change control, and risk assessments.
- Participate in internal audits, vendor audits, and regulatory inspections (FDA, EMA, WHO).
- Maintain and oversee Quality Management System (QMS) documentation and records.
- Support quality training programs and ensure compliance awareness across teams.
- Review, investigate, and track OOS, OOT, and product complaints.
- Support validation and qualification activities as required.
- Ensure data integrity and adherence to ALCOA+ principles.
Qualifications:
- Bachelor's degree in pharmacy, Life Sciences, Chemistry, or a related field.
- 5+ years of Quality Assurance experience in a pharmaceutical environment.
- Strong working knowledge of GMP regulations and FDA guidelines.
- Hands-on experience with documentation control systems and QMS tools.
- Excellent analytical, communication, and problem-solving skills.