Manager - QA, QC, Analytical & Microbiology

Flychem · India

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.