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Quality Control Technician Ii

3-5 years
Not Disclosed
10 July 26, 2024
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, 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 Summary:

We are seeking a Quality Control Analyst I to join our team. As a leading manufacturer of generic medicines, we are committed to making good health more affordable and accessible to millions around the world. In this role, you will be responsible for ensuring the quality of our products by performing analytical tests, investigating deviations, and maintaining laboratory records.

Key Responsibilities:

  • Ensure 24/7 audit readiness and participate in internal, external, and regulatory audits.
  • Investigate and report on LIR, OOS, OOT, and borderline results.
  • Support the sharing of required documents from QC to RA and other departments.
  • Determine team priorities and coordinate with the team leader/manager.
  • Ensure compliance with housekeeping, cGMP, GLP, and safety guidelines in the laboratory.
  • Perform sampling and analysis of raw materials, finished goods, intermediates, and cleaning samples.
  • Enter results in analytical sheets, QA forms, LIMS, and online documentation.
  • Perform analytical tests according to monographs and SOPs.
  • Calibrate and verify instruments.
  • Maintain reserved samples room and chambers/autoclaves/incubators.
  • Assist in preparing documents related to the department (e.g., STPs, SOPs).
  • Ensure timely sampling of finished products, raw materials, and intermediates, and sending samples to outside laboratories for analysis.
  • Maintain stock records of chemicals and reconcile standards.

Requirements:

  • Bachelor's or Master's degree in Chemistry or B-Pharm
  • 3-5 years of experience in a quality control laboratory
  • Reports to Quality Control Analyst II

What We Offer:

  • A dynamic and diverse work environment
  • Opportunities for professional growth and development
  • A commitment to equal employment opportunity and a diverse and inclusive workplace

How to Apply:

If you are a motivated and experienced quality control professional looking to join a global leader in the pharmaceutical industry, please submit your application. We are committed to providing an accessible candidate experience, so please advise us of any accommodations needed to support you throughout the recruitment and selection process.