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Quality Control Analyst Ii

10+ 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 an experienced Microbiology Laboratory Manager 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 managing the day-to-day operations of our microbiology laboratory, ensuring compliance with GXP regulations, and leading investigations into deviations, OOS, OOT, and other analytical test results.

Key Responsibilities:

  • Manage the microbiology laboratory, ensuring compliance with GXP regulations and overseeing daily operations.
  • Investigate deviations, OOS, OOT, and other analytical test results, and prepare reports.
  • Prepare quality management system documents and raise purchase requisitions for laboratory supplies.
  • Develop and execute protocols for validation and study activities.
  • Perform instrument calibration, preventive maintenance, and malfunctioning management.
  • Ensure timely completion of investigations, change controls, and CAPAs.
  • Provide technical expertise and support during customer, regulatory, and internal audits.
  • Develop and implement corrective and preventive actions to ensure compliance with regulatory requirements.

Technical Skills:

  • Bacterial Endotoxin Test (Gel Clot & Kinetic Method)
  • Sterility Test by Direct Inoculation & Membrane Filtration Method & Validation
  • Microbial Limit Test & Validation
  • Microbial Analysis of Water (WFI, PW, RW, RO, SW, PSC)
  • Identification of Isolates
  • Culture Suspension preparation 10 – 100 CFU/ml
  • Microbial Culture Maintenance
  • Growth Promotion & Inhibitory Test of Prepared Culture Media
  • Environment Monitoring Program – Settle plate, Air Sampling, Surface monitoring (By swab and contact Plate), Personnel monitoring in Aseptic Area
  • Hold Time Study of Sterilized Garments
  • Disinfectant Efficacy Test
  • UV Efficacy Test
  • Media fill Validation, Disinfectant validation, Preservative efficacy test, Preparation of Environment Monitoring & Water Trends

Requirements:

  • 10+ years of relevant experience in microbiology laboratory management
  • MSc in Microbiology
  • FDA approval in Microbiology is preferred

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 microbiology 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.