Quality Control Assistant (QC Assistant)

Department: Quality Control

Designation: Quality Control Assistant

Reporting To: QC Officer / QC Executive / QC Manager

Industry: Pharmaceutical / API Manufacturing

Experience: 0–3 Years

Employment Type: Full-Time

Location: turbhe

1. Job Purpose

To support routine Quality Control activities including sampling, testing, documentation, laboratory housekeeping, and maintenance of laboratory records in accordance with GMP, GLP, approved SOPs, specifications, and company quality standards.

1. Key ResponsibilitiesA. Laboratory Testing

- Assist in routine testing of raw materials, intermediates, APIs, finished products, and other samples as per approved specifications and SOPs.
- Perform basic chemical and physical analysis under the supervision of senior QC personnel.
- Prepare samples, reagents, solutions, and standards as required.
- Record test results accurately in laboratory worksheets, registers, and analytical records.
- Inform the senior QC personnel immediately of any abnormal or unexpected results.

B. Sampling
- Assist in sampling of raw materials, packing materials, intermediates, and finished products as per approved sampling procedures.
- Ensure proper labeling and identification of samples.
- Maintain sample traceability and transfer samples to the laboratory as per procedures.

C. Laboratory Documentation
- Maintain analytical worksheets, logbooks, registers, and other QC records.
- Follow Good Documentation Practices (GDP) while recording laboratory activities.
- Ensure all entries are accurate, legible, complete, and traceable.
- Maintain records of reagent and standard preparation, usage, and expiry.

D. Instruments & Equipment
- Assist in operation of laboratory instruments under supervision.
- Ensure instruments are clean and properly maintained.
- Record equipment usage and maintain instrument logbooks.
- Inform senior personnel about equipment malfunction or abnormal performance.
- Support calibration and preventive maintenance activities.

E.



Reagents & Solutions
- Prepare laboratory reagents, volumetric solutions, buffers, and other solutions as per approved procedures.
- Properly label all prepared solutions with preparation date, expiry/retest date, and other required details.
- Maintain records of preparation and standardization where applicable.
- Ensure expired or unsuitable reagents are identified and disposed of according to procedures.

F. GMP / GLP Compliance
- Follow applicable GMP, GLP, SOPs, safety requirements, and laboratory procedures.
- Maintain cleanliness and housekeeping of the laboratory.
- Ensure proper handling, storage, and disposal of chemicals and laboratory waste.
- Report any deviation, abnormal observation, or safety concern to the supervisor.

G. Stability & Retention Samples
- Assist in collection, labeling, storage, and retrieval of stability samples.
- Maintain stability sample records and storage conditions.
- Assist in management of retention samples as per approved procedures.

H. Audit & Inspection Support
- Support preparation of laboratory documents and records for internal audits, customer audits, and regulatory inspections.
- Ensure laboratory records are readily available and properly maintained.
- Assist in addressing routine audit observations under the guidance of senior QC personnel.

1. Key Performance Indicators (KPIs)

- Accuracy and completeness of analytical records.
- Timely completion of assigned testing activities.
- Compliance with GMP/GLP and SOP requirements.
- Proper maintenance of laboratory records and logbooks.
- Correct preparation and labeling of reagents and solutions.




- Laboratory housekeeping and safety compliance.
- Proper handling and traceability of samples.

1. Educational Qualification

Essential:

- B.Sc. / M.Sc. in Chemistry, Analytical Chemistry, Pharmaceutical Chemistry, or a related field.

Preferred:

- B.Pharm / Diploma in Pharmacy or relevant laboratory qualification.
- Basic knowledge of analytical laboratory practices.

1. Experience

- 0–3 years of relevant experience in Quality Control / Analytical Laboratory in a pharmaceutical, API, chemical, or related manufacturing industry.
- Freshers with relevant educational qualifications may also be considered.

1. Technical Knowledge

- Basic knowledge of pharmaceutical/API analysis.
- Understanding of laboratory safety practices.
- Basic knowledge of:
- pH meter
- Analytical balance
- UV-Visible spectrophotometer
- HPLC/GC – basic exposure preferred
- Karl Fischer – basic exposure preferred
- Melting point / physical testing equipment
- Knowledge of GMP, GLP, GDP, and laboratory SOPs.

1. Required Competencies

- Attention to detail
- Good laboratory practices
- Accuracy in documentation
- Basic analytical and problem-solving skills
- Valuable communication skills
- Teamwork
- Time management
- Willingness to learn
- Safety-conscious approach
- Quality-focused mindset

1. Reporting & Coordination

Reports To: QC Officer / QC Executive / QC Manager

Coordinates With:

Quality Assurance | Production | Warehouse | R&D; | Engineering | EHS

1. Overall Responsibility

The Quality Control Assistant is responsible for supporting laboratory testing, sampling, documentation, equipment handling, reagent preparation, and other QC activities while ensuring compliance with GMP, GLP, approved SOPs, specifications, safety requirements, and company quality standards. How to Apply / Contact HR For further details, please contact:

Sandhya – HR (phone hidden)

[email protected]

Pay: ₹18,000.00 - ₹25,000.00 per month

Work Location: In person

📌 Quality Control Officer (Navi Mumbai)
🏢 Great Pacific Export
📍 Navi Mumbai