Quality Control Executive

Job Description :-

Perform comprehensive physico-chemical and instrumental analysis of raw materials, intermediates, finished products, and stability samples in accordance with approved specifications, SOPs, and global regulatory guidelines.

Independently operate, troubleshoot, and maintain analytical instruments including HPLC, GC, UV-Vis, FTIR, Karl Fischer, and other QC laboratory equipment, ensuring compliance with calibration and qualification schedules.

Review and approve analytical data, analytical reports, COAs, and regulatory documentation with high accuracy and compliance focus.

Lead investigations for OOS, OOT, deviations, CAPA, and change controls, ensuring timely closure and alignment with regulatory expectations.

Prepare, review, and revise SOPs, STPs, GTPs, instrument operation procedures, and validation protocols as per GMP and global quality standards.

Perform data trending, analytical interpretation, method troubleshooting, and support method validation, verification, and transfer activities.

Ensure readiness and active participation in regulatory inspections and customer audits including WHO-GMP, USFDA, MHRA, Health Canada, EU, and ISO-certified medical device audits; provide evidence-based responses and support compliance actions.

Coordinate with cross-functional departments including Production, QA, R&D, and Engineering to ensure analytical support for batch release and process improvements.

Maintain 21 CFR Part 11compliant documentation, data integrity standards (ALCOA+), and ensure adherence to GMP, GLP, ICH guidelines, and applicable pharmacopeias (IP/BP/USP/EP).

Monitor inventory of standards, reagents, columns, and laboratory consumables, ensuring availability in alignment with testing schedules.

Guide and mentor junior analysts, enabling technical capability building and ensuring adherence to safety and quality practices.

Requirements

M.Sc. Chemistry with 78 years of hands-on Quality Control experience in regulated pharmaceutical and/or medical devices manufacturing.

Strong analytical expertise in HPLC, GC, IR, UV-Vis, Dissolution, KF, and physicochemical testing techniques.

Proven exposure to regulatory inspections: WHO-GMP, USFDA, Health Canada, ISO-13485, EU regulatory audits, and customer audits.

In-depth understanding of GMP, GLP, ICH Q series, ISO-17025/ISO-13485, 21 CFR Part 11, and data integrity requirements.

Strong documentation, communication skills, and ability to prepare regulatory-compliant analytical records.

Ability to independently manage QC operations, analytical troubleshooting, and regulatory audit readiness.

Preferably male candidate willingness to work rotational shifts based on operational requirements.

Benefits

Opportunity to lead analytical investigations and contribute to global regulatory compliance.

Growth into QC Lead / Manager level roles based on performance and leadership capabilities.

Continuous learning through cross-functional collaboration and audit participation.

Supportive and structured environment encouraging technical and professional development