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Quality Assurance Assistant Manager Micro
1 month ago
Job Summary
We are seeking a highly skilled Quality Assurance Assistant Manager Micro to join our team at Par Formulations. The successful candidate will be responsible for reviewing microbial analytical documents, qualification documents, and laboratory reports.
Key Responsibilities
- Review of microbial analytical documents of raw materials, packing materials, in-process, hold time, finished product, stability, analytical method transfer/validation/verification protocol, reports, and raw data.
- Review of qualification documents (IQ/OQ/PQ) of equipment's/instruments.
- Investigation and review reports of laboratory OOS, OOT, incidents.
- Discussion of QMS action points with CFT and to ensure closure within TCD.
- Provide support in assessing Change Control requests.
- Computer System Validation (CSV) deliverable preparation/review.
- Audit trail review of laboratory instruments.
- Handling of Change control, CAPA.
- Minimum 10-14 years of work experience in Microbial Analytical activities.
- Awareness of QMS procedures.
- Awareness of software compliance and audit trail review.
- Knowledgeable on guidelines per regulatory requirements, e.g., ICH, US FDA, 21 CFR.
Commitment to Diversity, Equity, and Inclusion
At Par Formulations, our diversity unites and empowers us as One Team, and we are committed to cultivating and valuing each person's unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.