Executive / Asst. Manager - QC(P)

Quality HR Services

5 - 10 years

10 - 12 Lacs

vapi

Posted:22 hours ago| Platform:

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Skills Required

capa glp gmp oos oot method validation finished goods qc management ich-gcp guidelines analytical method development documentation hplc lims qc packing material quality management sop qms method development 21 cfr protocols gc finished products

Work Mode

Work from Office

Job Type

Full Time

Job Description

Responsibilities:

Analytical Operations:
Perform and supervise analysis of Raw Materials (RM), Packing Materials (PM), and Finished Goods (FG).
Operate and maintain analytical instruments
:- HPLC, GC, UV-Vis, FTIR, Dissolution Apparatus
Ensure compliance with GLP, 21 CFR Part 11, and data integrity standards.
Review and approve analytical reports and LIMS entries , Quality Systems & Compliance
Implement and monitor Quality Management Systems (QMS).
Lead investigations for OOS, OOT, Deviations, and Laboratory Incidents.
Prepare and review SOPs, STPs, and validation protocols.
Ensure audit readiness and support regulatory inspections (USFDA, WHO-GMP, etc.) Documentation & Reporting
Maintain accurate documentation in LIMS and ensure traceability.
Prepare investigation reports, CAPA, and trend analysis.
Coordinate with cross-functional teams for timely release and compliance ,Project & Team Leadership
Mentor and train QC analysts on instrumentation and regulatory practices.
Lead or contribute to method validation, tech transfer, and stability studies.
Drive continuous improvement initiatives and lean lab practices.

Required skills:

Strong command of 21 CFR Part 11, GLP, and GMP guidelines.
Proficiency in LIMS and electronic documentation systems.
Expertise in handling OOS/OOT investigations and CAPA implementation.
Experience in regulatory audits, data integrity, and instrument calibration.
Knowledge of ICH guidelines, method development, and stability protocols Preferred Attributes.
FDA-approved analyst (preferred).
Experience in handling project work related to analytical method development or tech transfer.
Excellent communication, leadership, and problem-solving skills.

Required Qualification: -

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