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4-10 years
Not Disclosed
10 Feb. 10, 2025
Job Description
Job Type: Remote 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

Position: Senior Executive - Method Validation
Department: Method Validation
Location: Unit 3
Experience Required: 4-10 years
Educational Qualification: M.Sc
Date Posted: 25-01-2024


Job Summary:

We are seeking a skilled Senior Executive for our Method Validation team to perform method validation, stability sample analysis, and ensure compliance with cGMP standards. This role involves documentation preparation, vendor coordination for calibration, and laboratory equipment management. The ideal candidate will have experience in analytical testing methods such as CEX-HPLC, SE-HPLC, ELISA, and Capillary Electrophoresis.


Key Responsibilities:

  1. Method Validation & Data Review:

    • Perform method validation and stability sample analysis.
    • Review and interpret analytical data to ensure accuracy and compliance with regulatory standards.
  2. Document Preparation & Review:

    • Prepare and review various documents such as Specifications, STPs, TDS, SOPs, COA, MVP, MVR, MTR, and more.
  3. Coordination with Vendors:

    • Coordinate with vendors for external calibration and collaborate with QC personnel for in-house calibration and verification of laboratory instruments.
  4. QC Materials Management:

    • Manage and coordinate the indenting of QC materials (chemicals, standards, kits, and consumables).
  5. Equipment Maintenance & Management:

    • Oversee the maintenance and management of laboratory equipment and instruments to ensure proper functioning and compliance.
  6. Analyst Qualification & Training:

    • Ensure the qualification of analysts and provide training to QC employees.
  7. QMS Activities:

    • Initiate, investigate, and track Quality Management System (QMS) activities to ensure compliance.
  8. Compliance with cGMP:

    • Ensure that all QC laboratory activities are conducted in compliance with current Good Manufacturing Practices (cGMP).

Skills & Qualifications:

  • Educational Qualification:

    • M.Sc., M. Pharm, or a Master’s degree in Biotech or related subjects.
  • Experience:

    • 3-7 years of experience in analytical testing methods such as CEX-HPLC, SE-HPLC, ELISA, and Capillary Electrophoresis.
  • Computer Skills:

    • Proficiency in MS Word, PowerPoint, and other relevant software.
  • Additional Responsibilities:

    • Perform additional tasks as directed by the supervisor.