JOB DESCRIPTION
Position Details
Designation QC Officer / QC Executive
Department Quality Control (QC)
Reporting To QC Manager / Head – Quality
Location Manufacturing Plant
Qualification B.Pharm / M.Pharm / B.Sc. / M.Sc. (Chemistry / Microbiology / Relevant Science)
Experience 1–2 years in Quality Control, preferably in Pharmaceutical / Veterinary / Nutraceutical / Food or Feed Industry
1. Job Purpose
The QC Officer / QC Executive shall be responsible for sampling, testing, analysis, documentation, and release recommendations for raw materials, packaging materials, in-process materials, finished products, and stability samples to ensure that products comply with approved specifications and applicable quality standards.
2. Key Roles and Responsibilities
A. Raw Material and Packaging Material Testing
Perform sampling and testing of raw materials as per approved specifications and Standard Operating Procedures (SOPs).
Test packaging materials, where applicable, against approved specifications.
Ensure proper identification and status labeling of sampled and tested materials.
Maintain complete records of analysis and test results.
B. In-Process Quality Control
Perform in-process testing and monitoring during manufacturing operations.
Verify critical quality parameters during production.
Communicate any abnormal results or deviations immediately to the QC Manager and concerned department.
Ensure appropriate documentation of in-process testing activities.
C. Finished Product Testing
Perform physical, chemical, and instrumental analysis of finished products as per approved specifications.
Ensure testing is completed within defined timelines.
Prepare and review analytical records.
Report results accurately and promptly.
D. Laboratory Equipment and Instruments
Operate and maintain laboratory instruments and equipment as per approved SOPs.
Ensure calibration and verification status of instruments is maintained.
Maintain equipment usage logs and calibration records.
Report equipment malfunction or breakdown immediately.
Ensure instruments are used only within their approved operating conditions.
E. Documentation and Data Integrity
Prepare and maintain:
Analytical worksheets
Raw material testing records
In-process testing records
Finished product analysis reports
Certificates of Analysis (COA), where authorized
Instrument logbooks
Reagent and standard registers
Ensure all entries are accurate, legible, contemporaneous, and traceable.
Follow Good Documentation Practices (GDP) and Data Integrity principles.
F. Stability and Retention Samples
Assist in stability studies as per the approved stability protocol.
Perform testing of stability samples at defined intervals.
Maintain stability records and reports.
Ensure proper storage and control of retention samples.
G. Reagents, Standards and Laboratory Management
Maintain inventory and proper storage of chemicals, reagents, reference standards, and working standards.
Ensure proper labeling and validity status of reagents and solutions.
Prepare reagents and volumetric solutions as per approved procedures.
Maintain laboratory cleanliness and housekeeping.
H. Deviations and Out-of-Specification Results
Immediately report any Out-of-Specification (OOS), Out-of-Trend (OOT), deviation, or abnormal observation.
Participate in laboratory investigations and root cause analysis.
Support implementation of Corrective and Preventive Actions (CAPA).
I. Compliance and Quality Systems
Follow applicable GMP, GLP, SOPs, specifications, and company quality policies.
Participate in internal audits, external audits, and regulatory inspections.
Support implementation of audit observations and CAPA.
Ensure compliance with safety requirements within the laboratory.
3. Key Accountabilities
Timely testing and analysis of samples.
Accuracy and reliability of analytical results.
Compliance with approved specifications and SOPs.
Proper maintenance of laboratory records.
Timely reporting of abnormal results.
Proper maintenance and calibration status of laboratory equipment.
Compliance with GDP, GLP, GMP, and Data Integrity requirements.
4. Skills and Competencies Required
Technical Skills
Knowledge of Quality Control laboratory operations.
Knowledge of analytical testing techniques.
Understanding of GMP / GLP / GDP practices.
Knowledge of laboratory instruments and equipment.
Understanding of specifications, SOPs, STPs, and COA.
Knowledge of OOS, OOT, Deviations, and CAPA.
Behavioral Competencies
Attention to detail.
Analytical and problem-solving ability.
Integrity and accountability.
Documentation discipline.
Teamwork and coordination.
Ability to work under defined timelines.
5. Preferred Experience
Experience in one or more of the following industries will be preferred:
Veterinary Healthcare Products
Pharmaceutical Manufacturing
Animal Feed Supplements
Nutraceutical Products
Food Manufacturing
Chemical Manufacturing
Pay: ₹25,000.00 - ₹35,000.00 per month
Benefits:
- Paid sick time
- Paid time off
- Provident Fund
Work Location: In person
