Flychem
Website:
flychem.com
Job details:
Flychem is looking for an experienced QA, QC, Analytical and Microbiology professional to take ownership of quality systems and laboratory operations covering raw materials, in-process materials and finished goods, including analytical testing, microbiology, method validation, stability, investigations and product release.
Note: You can apply here on LinkedIN and share your CV to careers@flychem.com.
Key Responsibilities
- Lead QA/QC for raw materials, packaging materials, intermediates, in-process samples and finished goods.
- Establish and maintain specifications, SOPs, STPs, sampling plans and release criteria.
- Review and approve COAs, batch records, analytical reports and release documentation.
- Manage testing by HPLC, GC, UV-Vis, FTIR, Karl Fischer, titration and other relevant techniques.
- Develop, optimize, transfer and validate analytical methods.
- Handle OOS, OOT, deviations, CAPA, change controls and non-conformances with root-cause investigation.
- Plan and review stability studies, impurity profiles, retest periods and shelf-life data.
- Ensure instrument qualification, calibration, preventive maintenance and data-integrity controls.
- Manage reference standards, reagents, columns and laboratory documentation.
- Coordinate with R&D; and manufacturing during development, scale-up and technology transfer.
- Perform or supervise microbial limit testing, total aerobic microbial count, yeast & mold and specified pathogen testing.
- Coordinate/review preservative efficacy / challenge testing, bioburden and microbiological method suitability/validation.
- Oversee water microbiology, hygiene/environmental monitoring and microbiological investigations where applicable.
- Qualify vendors and review incoming material quality performance.
- Support customer/regulatory audits, technical queries and quality agreements.
- Train and supervise QC analysts while maintaining GMP / GLP / ISO-aligned systems.
Preferred Profile
- M.Sc Chemistry / Analytical Chemistry / Microbiology / M.Pharm / B.Pharm or equivalent.
- 5-10+ years of QA/QC, analytical laboratory or microbiology experience.
- Strong hands-on understanding of HPLC/GC, analytical method development and validation.
- Working knowledge of microbiological QC for cosmetics, pharmaceuticals, specialty chemicals or personal-care products.
- Good understanding of OOS, CAPA, deviations, change control, stability and audit documentation.
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