Job Description

Job Description

Department: Quality Control Analytical

Role: QC (Raw Material/Packing Material)

Role Summary

  • As a QC Analytical person, the role involves managing samples from receipt to release, ensuring timely analysis and accurate documentation in compliance with GMP/GLP standards. Responsibilities include performing analytical testing, compiling results, and supporting equipment qualification, calibration, and maintenance. The position also requires participation in stability studies, handling deviations and corrective actions, and maintaining training and regulatory records. Additionally, the role supports audit readiness, SOP development, and continuous improvement initiatives to uphold quality systems and regulatory compliance.

Responsibilities

Roles & Responsibilities

  • Sample management, including sample in/out, Entry/Exit of samples, Test sample requests, and management of sample request forms for QC laboratory activity.
  • Ensure that all raw material and packing material testing and method verification activity is carried out per schedule and per GMP. Ensure that records are maintained to appropriate requirements.
  • Sampling of Raw material, packing material and Physical verification of consumable as per priority of production and release in accordance with quality standards and procedures.
  • Preparation of Raw material/ Packing material specifications and DRS. Analysis of Packing material (Primary, Secondary and Tertiary packing materials).
  • Support laboratory operations including but not limited to method verification, equipment qualification, calibration, cleaning and maintenance, purchase and receipt of reagents and consumables and document management.
  • Responsible for analysis of samples, following test methods, generation and compilation of results, data packets preparation and submission for review of results in a timely manner.
  • Reading and understanding the test procedure and the requirements per USP, EP, JP and IP.
  • Participate in inspection and ensure that the laboratory and documents are in a constant state of regulatory compliance and inspection readiness.
  • To assist in writing SOP documents, change plan or change records (document revisions) supporting continuous improvement of test procedures.
  • To carry out completion and review of GMP Documentation of data sheets or LIMS software.
  • To carry out QC sample receipt, assay and release procedures.
  • Support Audit preparation and any audit related activity
  • Responsible for maintaining and Training records for the QC laboratory in accordance with GLP compliance and any other work assigned by the Supervisor or Head of Department.

Basic Requirements

  • Qualification: Master’s degree in science
  • Good verbal and email communication skills
  • Attention to detail and strong compliance mindset
  • Curiosity to read, learn and working across cross-functional teams
  • Basic MS Office: Word, Excel, PowerPoint
  • Flexible to work in shifts as per operational requirements.

Qualifications

MSC/ BSC- (Chemistry/ Analytical / Microbiology/ Biotechnology)


Job Details

Role Level: Not Applicable Work Type: Full-Time
Country: India City: Ahmedabad ,Gujarat
Company Website: http://www.amneal.com Job Function: Analyst
Company Industry/
Sector:
Pharmaceutical Manufacturing

What We Offer


About the Company

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