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Trainee, Quality Control-Arpl-Qcst Ar

0-2 years
Not Disclosed
10 Oct. 31, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/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

Position: Trainee, Quality Control (ARPL-QCST AR)

Date Posted: October 16, 2025
Location: Bangalore, Karnataka, India – 560099
Company: Apotex / ApoPharma


About the Company

ApoPharma, a member of the Apotex Group of Companies, focuses on discovering, developing, and providing innovative medicines to improve the lives of patients with serious or life-threatening diseases.
A major area of research is understanding the pathological role of iron in human diseases and developing novel therapies targeting these conditions.


Job Summary

The trainee will be responsible for:

  • Performing method verification and validation of compendial/pharmacopeial updates and Supplier Driven Changes (SDCs).

  • Conducting method validation for cleaning verification.

  • Preparing method verification and validation protocols, reports, and in-house specifications.

  • Analyzing raw materials, excipients, in-process, and finished products in compliance with regulatory standards.


Key Responsibilities

  • Conduct analysis of compendial, raw material, excipient, in-process, and finished product samples using approved analytical methods.

  • Prepare and review:

    • Memos,

    • Method Verification/Validation protocols,

    • Reports and method transfer summaries.

  • Participate in OOS/OOT investigations and provide technical support for root cause analysis.

  • Review compendial changes and perform method verification accordingly.

  • Execute cleaning validation as per approved protocols.

  • Maintain compliance with regulatory, safety, and cGLP requirements.

  • Prepare and update specifications and analytical methods in alignment with compendial and regulatory requirements.

  • Ensure proper documentation and record maintenance for all laboratory activities.

  • Promote teamwork and adherence to Apotex values: Collaboration, Courage, Perseverance, and Passion.

  • Comply with all quality, ethics, safety, and HR policies.

  • Perform any other assigned duties related to Quality Control operations.


Education Requirements

  • M.Sc. or B.Pharm (or equivalent qualification)


Skills & Abilities

  • Proficiency in Microsoft Office (Word, Excel)

  • Strong analytical and planning skills

  • Ability to prioritize and meet timelines effectively

  • Hands-on experience with HPLC operation and data analysis

  • Strong documentation and communication abilities


Experience

  • Fresher (entry-level position)


Additional Information

Apotex is committed to fostering an inclusive and accessible workplace.
Applicants with disabilities may request reasonable accommodation during the recruitment process.


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