Department: Quality Control (QC) Designation: Sr. Executive-B Qualification: B.Sc./M.Sc. in Chemistry or relevant scientific discipline Experience: 5-8 years in QC Documentation within a pharmaceutical formulation plant.

Key Responsibilities:

Prepare, review, and maintain QC documents, including SOPs, specifications, STPs, protocols, and reports.

Review and maintain analytical records, raw data, and laboratory documentation.

Ensure compliance with cGMP, GLP, data integrity, and ALCOA+ guidelines.

Maintain and control QC documents, logbooks, registers, and analytical records.

Coordinate with QC sections for timely documentation, review, and closure of discrepancies.

Support internal audits, regulatory inspections,



and documentation compliance activities.

Ensure proper handling of deviations, OOS/OOT documentation, CAPA, and change controls.

Maintain documentation in accordance with applicable regulatory requirements and company procedures.

Required Skills:

Strong knowledge of pharmaceutical QC documentation and cGMP requirements.

Experience in formulation QC documentation.

Valuable understanding of data integrity and laboratory practices.

Strong documentation, review, and coordination skills.

📌 Sr Executive-B (QC) (Ankleshwar)
🏢 KEC International
📍 Ankleshwar