Instagram
youtube
Facebook

Quality Control Analyst I

5-10 years
Not Disclosed
10 Dec. 27, 2024
Job Description
Job Type: Full Time Education: MSc 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 Title: Stability Analyst / Method Validation Specialist
Company: Teva Pharmaceuticals

Company Overview:
Teva Pharmaceuticals is a global leader in the manufacturing of generic medicines, committed to making good health more affordable and accessible. With a presence in nearly 60 countries, Teva produces products included in the World Health Organization's Essential Medicines List. Teva’s medicines serve over 200 million people daily, making a profound impact on global health. The company strives to continually improve and expand its contributions to healthcare.

Role Overview:
The Stability Analyst / Method Validation Specialist is responsible for performing stability analysis, method transfer, and method validation in compliance with current guidelines. This role also includes the preparation of related documents and protocols, instrument calibration and validation, and the use of software tools like LSCMS. The successful candidate will ensure all activities comply with current standards and regulations, and contribute to maintaining the quality of pharmaceutical products.

Key Responsibilities:

  • Stability Analysis: Perform stability analysis on pharmaceutical products and review the corresponding documents to ensure compliance with regulatory requirements.
  • Method Transfer & Validation: Conduct method transfer and method validation activities, including preparation of protocols and reports (e.g., Method Transfer Protocols (MTP), Method Transfer Report (MTR), Test Data Sheets (TDS)).
  • Instrument Calibration & Validation: Calibrate and validate laboratory instruments and equipment to ensure accuracy and compliance.
  • Documentation: Prepare and review documents related to stability analysis, method transfer/validation, and calibration in compliance with current guidelines and SOPs.
  • Data Entry: Enter stability sample results in LIMS (Laboratory Information Management System) for further analysis and reporting.
  • Software Handling: Manage and use LSCMS (Liquid Scintillation Counting Mass Spectrometry) software to support analysis and data management.

Qualifications and Experience:

  • Education: M.Sc. in Chemistry or a related field.
  • Experience: 5 to 10 years of experience in a relevant role within the pharmaceutical industry, with expertise in stability analysis, method transfer, and method validation.
  • Skills:
    • Strong knowledge of current guidelines for stability analysis and method validation.
    • Experience with instrument calibration, validation processes, and laboratory documentation.
    • Proficiency with LSCMS software and LIMS systems.
    • Strong attention to detail, with a focus on compliance and regulatory standards.
    • Ability to work independently and as part of a team in a dynamic environment.

Teva’s Equal Employment Opportunity Commitment:
Teva Pharmaceuticals is committed to providing equal employment opportunities to all employees and applicants, regardless of age, race, gender, disability, sexual orientation, or other legally protected status. Teva is dedicated to fostering a diverse and inclusive workplace. If you require accommodations during the recruitment process, Teva will ensure an accessible experience.

Apply now to join a global leader in pharmaceuticals and make a meaningful difference in healthcare!