Quality Controller

Job Title: Quality Control

Department: Quality Control (QC)

Location: BADDI , HIMACHAL PRADESH

]Employment Type: Full-time

Job Summary:

The Quality Control (QC) Officer is responsible for ensuring that all pharmaceutical products meet established quality standards before release. This includes testing of raw materials, in-process samples, and finished products in compliance with cGMP, GLP, and regulatory requirements. The role involves coordination with production and QA teams to maintain product quality and ensure data integrity.

Key Responsibilities:

• Perform chemical, physical, and microbiological testing of raw materials, in-process samples, intermediates, and finished products as per standard test procedures (STPs).
• Conduct stability studies and maintain stability chambers as per ICH guidelines.
• Calibrate and maintain laboratory instruments (HPLC, GC, UV-Vis, FTIR, pH meter, balances, etc.) as per schedule.
• Review and record analytical data ensuring accuracy, completeness, and compliance with Good Laboratory Practices (GLP).
• Prepare and standardize reagents, solutions, and volumetric preparations.
• Maintain proper documentation of test results, logbooks, and reports in accordance with cGMP and company SOPs.
• Investigate OOS (Out of Specification), OOT (Out of Trend), and deviations, and assist in implementing corrective and preventive actions (CAPA).
• Ensure environmental monitoring and water analysis (Purified Water, WFI) as required.
• Coordinate with production and QA departments to ensure timely release of materials and products.
• Participate in internal and external audits and ensure audit readiness at all times.
• Ensure adherence to EHS (Environment, Health & Safety) and data integrity principles in all laboratory activities.

Qualifications and Experience:

• Education: B.Pharm / M.Pharm
• Experience: 2–5 years in a Quality Control department of a pharmaceutical manufacturing unit.
• Knowledge:

cGMP, GLP, and regulatory guidelines (WHO, USFDA, MHRA, etc.)
Analytical techniques (HPLC, GC, UV, IR, etc.)Documentation and data integrity practices

Skills and Competencies:

• Strong analytical and problem-solving skills
• Attention to detail and accuracy in documentation
• Good communication and teamwork skills
• Ability to work under pressure and meet deadlines
• Proficiency in MS Office and LIMS (Laboratory Information Management System)

Key Performance Indicators (KPIs):

• Timely completion of testing and release activities
• Compliance with cGMP, GLP, and audit standards
• Reduction in deviations, OOS/OOT incidents
• Data integrity and documentation accuracy

Job Type: Full-time

Pay: ₹35,435.90 - ₹60,219.08 per month

Benefits:

• Provident Fund

Work Location: In person