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Team Member Quality Control

1-3 years
Not Disclosed
10 Nov. 13, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Quality Control Analyst / Chemist

Department: Quality Control (QC)

Location: [Specify location, e.g., Hyderabad, India]

Job Type: Full-time | On-site | Quality Function

Experience Level: [Specify if applicable, e.g., 1–3 years]


Job Summary

We are seeking a skilled and detail-oriented Quality Control Analyst responsible for performing analytical testing and ensuring the quality and compliance of raw materials, packaging materials, intermediates, bulk, and finished products. The role involves routine analytical testing using advanced laboratory instruments and systems, documentation within SAP and LIMS, and adherence to cGMP and company quality standards.


Key Roles & Responsibilities

1. Analytical Testing & Instrument Operation

  • Perform chemical and instrumental analysis using Analytical Balance, Microbalance, pH Meter, Conductivity Meter, Karl Fischer (KF) Titrator, Auto Titrator, Halogen Moisture Analyzer, UV-Vis Spectrophotometer, IR Spectrometer, and Hot Air Oven.

  • Conduct instrumental analysis using HPLC and GC systems for routine testing.

  • Ensure accuracy, precision, and reliability in analytical results as per established specifications.

2. Sample Release & Documentation

  • Perform testing and release of raw materials, packaging materials, in-process, intermediate, bulk, and finished products in line with defined Service Level Agreements (SLA).

  • Document all analytical data, test reports, and observations in compliance with Good Documentation Practices (GDP).

3. LIMS & SAP System Activities

  • Execute SAP-related activities for sample registration, result entry, and approval workflows.

  • Prepare, review, and approve LIMS masters and ensure data integrity compliance.

  • Address and close LIMS tickets and Audit Trail observations within timelines.

4. Quality Compliance & Investigations

  • Report online incidents, Out-of-Specification (OOS), and Out-of-Trend (OOT) results as per defined SOPs.

  • Support Quality Assurance (QA) and immediate supervisor in root cause investigations and CAPA implementation.

  • Ensure compliance with internal quality systems, cGMP, and regulatory standards during all QC activities.


Qualifications

Education:

  • M.Sc. in Chemistry or equivalent discipline.

Experience:

  • Prior experience in a pharmaceutical Quality Control laboratory preferred.


Skills & Competencies

Technical Skills

  • Proficiency in operation and troubleshooting of analytical instruments (HPLC, GC, KF, UV, IR, etc.).

  • Strong understanding of cGMP, GLP, and data integrity principles.

  • Working knowledge of SAP and Labware LIMS systems.

  • Knowledge of analytical documentation, specifications, and SOP-based testing.

Behavioral Skills

  • Strong attention to detail and accuracy.

  • Good communication and teamwork abilities.

  • Analytical thinking and problem-solving skills.

  • Ability to work effectively in a regulated and time-bound environment.