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Executive Quality Control

Alkem Laboratories Ltd.
Alkem Laboratories Ltd.
5-9 years
₹ 500,000 - 800,000 per year
10 Dec. 31, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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 Description: Quality Control Specialist


Responsibilities:

  1. Compliance and Standards:

    • Ensure adherence to Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) in all quality control activities.
    • Conduct and participate in both internal and external audits to verify and maintain quality standards.
  2. Testing and Documentation:

    • Perform quality testing of raw materials, intermediates, and finished products using advanced analytical techniques (e.g., HPLC, GC, FTIR, UV-Vis).
    • Maintain precise and timely documentation for all testing activities in compliance with regulatory and company standards.
  3. Problem-Solving and CAPA:

    • Support root cause analysis for non-conformances and implement Corrective and Preventive Actions (CAPA) to mitigate risks.
    • Collaborate with cross-functional teams to address quality issues effectively.
  4. Equipment Maintenance:

    • Calibrate, maintain, and troubleshoot laboratory instruments and equipment to ensure accurate and reliable testing results.
    • Maintain equipment logs and documentation as required.
  5. Regulatory and Process Support:

    • Ensure compliance with regulatory requirements, such as FDA, WHO, and ICH guidelines.
    • Provide support for quality control process improvement initiatives and validation activities.

Qualifications and Experience:

  • Education:
    • Bachelor’s or Master’s degree in Chemistry, Pharmacy, or a related field.
  • Experience:
    • 2–5 years of quality control experience in the pharmaceutical, chemical, or food industry.

Skills and Competencies:

  1. Technical Skills:

    • Proficiency in analytical techniques such as HPLC, GC, FTIR, and UV-Vis spectroscopy.
    • Familiarity with regulatory requirements and industry guidelines (FDA, WHO, ICH).
    • Proficient in laboratory software (e.g., LIMS) and standard MS Office tools.
  2. Attention to Detail:

    • Strong focus on accuracy in testing and documentation to ensure data integrity.
  3. Problem-Solving:

    • Analytical mindset for troubleshooting laboratory issues and supporting CAPA initiatives.
  4. Communication and Teamwork:

    • Strong verbal and written communication skills for collaborating with internal teams and external stakeholders.
    • Ability to work effectively as part of a team in a fast-paced, regulated environment.

This role is critical to ensuring product quality, regulatory compliance, and the overall reliability of laboratory processes within the organization.