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Quality Control Analyst

10-12 years
Not Disclosed
10 Nov. 30, 2024
Job Description
Job Type: Full Time Education: 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

Location: Gajraula, India, 244235
Company: Teva Pharmaceuticals


Who We Are

Teva Pharmaceuticals is dedicated to making good health more affordable and accessible worldwide. As a leading manufacturer of generic medicines, Teva provides many products featured on the World Health Organization’s Essential Medicines List. With a mission to help millions of people live healthier lives, Teva operates across nearly 60 countries, employing a diverse and talented workforce. Every day, millions of people trust Teva’s medicines to improve their health.


Key Responsibilities

  • Laboratory Oversight:

    • Serve as the Subject Matter Expert (SME) in Wet Analysis Laboratory operations.

    • Supervise the laboratory's day-to-day operations to ensure compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).

    • Review daily calibration data and analytical data.

  • Investigation and Compliance:

    • Investigate deviations, Out of Specification (OOS), Out of Trend (OOT), Alert Limit, and Atypical Analytical Test results.

    • Ensure timely and adequate completion of investigations, change controls, and Corrective and Preventive Actions (CAPA).

    • Prepare and maintain documentation, including Standard Test Procedures (STP) for wet analysis laboratory activities.

  • Audit and Regulatory Compliance:

    • Participate in audits, both internal and external (regulatory, customer, etc.), and explain laboratory-related findings.

    • Ensure laboratory operations are compliant with regulatory standards and Teva’s internal requirements.

  • Instrument Management:

    • Oversee instrument calibration, preventive maintenance, and malfunction management to ensure the continued functionality of laboratory equipment.

    • Raise purchase requisitions for items required for wet laboratory operations.

  • Validation and Study Execution:

    • Execute protocols and report on validation or study activities as required.


Qualifications and Experience

  • Educational Requirements:

    • Master’s degree in Chemistry (MSc Chemistry).

  • Experience:

    • 10 to 12 years of experience in a Quality Control laboratory, with a focus on wet analysis.

    • Proven experience in handling investigations, CAPA, and working in GXP-compliant environments.

  • Skills and Knowledge:

    • Strong understanding of analytical testing, instrumentation, and laboratory processes.

    • In-depth knowledge of deviation investigations and regulatory compliance.

    • Ability to explain and defend laboratory data and practices during audits.

    • Excellent documentation and reporting skills.


Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. We ensure that hiring and employment decisions are made without regard to race, age, sex, religion, disability, or any other legally protected status. Our workplace is diverse and inclusive, and we are committed to providing accommodations to support candidates throughout the recruitment process.


If you are passionate about contributing to healthcare innovation and ensuring high-quality standards in pharmaceutical operations, we invite you to apply.