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Quality Control Analyst I

5+ years
Not Disclosed
10 Nov. 30, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc. 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: Quality Control Analyst I

Location: Gwalior, India, 477117
Company: Teva Pharmaceuticals
Job ID: 58745


Who We Are

Teva Active Pharmaceutical Ingredients (TAPI) is the global leader in supplying Active Pharmaceutical Ingredients (APIs). We offer one of the most extensive portfolios in the industry with over 350 API products. TAPI is the trusted partner to 80% of the top 50 pharmaceutical companies, and our reliable history in the generic API industry, spanning more than 80 years, continues to make us a top supplier. Headquartered in Israel, Teva employs over 4,000 professionals at 14 sites across the globe. We are dedicated to continuing our leadership in the API market by leveraging our experience, technology, and exceptional customer service.


How You’ll Spend Your Day

As a Quality Control Analyst I, you will be responsible for ensuring quality control in various laboratory operations. Your duties will include:

  • Audit Readiness & Compliance:

    • Ensure continuous audit readiness (internal, external, and regulatory).

    • Participate in audits and support with relevant documentation and findings.

  • Investigation & Reporting:

    • Initiate and investigate Laboratory Incident Reports (LIR), Out of Specification (OOS), Out of Trend (OOT), and borderline results.

    • Report findings to the in-charge and ensure appropriate actions are taken.

  • Laboratory Testing & Sampling:

    • Conduct sampling and analysis of raw materials (RM), finished goods (FG), intermediates, and cleaning samples.

    • Record and report results in analytical sheets, QA forms, LIMS, and online documentation, ensuring compliance with data integrity standards.

    • Perform analytical tests according to established monographs and SOPs.

  • Instrument Calibration & Maintenance:

    • Responsible for the calibration and verification of laboratory instruments, including HPLC.

  • Documentation & Team Support:

    • Assist in the preparation of department documents like Standard Test Procedures (STPs) and SOPs.

    • Support the sharing of required documents between Quality Control (QC) and Regulatory Affairs (RA) or other departments.

  • Safety & Regulatory Compliance:

    • Follow and maintain safety guidelines and ensure compliance with cGMP, GLP, and 5-S principles in the laboratory.

    • Contribute to maintaining a safe working environment through CAPA and other safety programs.

  • Inventory Management:

    • Maintain chemical stock records and reconcile standards in the laboratory.

  • Efficiency Programs:

    • Support analysis reduction and QC efficiency enhancement initiatives.

  • Other Responsibilities:

    • Perform any other duties as assigned by the QC Manager or Group Leader QC.


Your Experience and Qualifications

  • Educational Requirements:

    • A Bachelor’s or Master’s degree in Science (Chemistry, Pharmaceutical Sciences, or related field).

  • Experience:

    • Minimum of 5 years of experience in a quality control laboratory, with exposure to HPLC and other relevant techniques.

  • Skills & Knowledge:

    • Strong understanding of laboratory operations, including analytical testing and instrumentation.

    • Experience with regulatory compliance, documentation, and audits.

    • Knowledge of data integrity norms and cGMP, GLP standards.

    • Strong communication and organizational skills.


Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is an equal opportunity employer. We provide employment opportunities without regard to age, race, gender, disability, religion, or any other legally protected status. We are committed to creating a diverse and inclusive workplace where everyone has the opportunity to succeed. If you require any accommodations during the recruitment process, please inform us, and we will ensure a smooth and accessible experience.


If you are passionate about quality control and want to join a global leader in the pharmaceutical industry, apply today!