Quality Analyst I

Teva Pharmaceuticals

3-6 years

Not Disclosed

India Navi Mumbai

10 Feb. 12, 2025

Job Description

Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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 Analyst I
Date: Feb 10, 2025
Location: Navi Mumbai, India, 400706
Company: Teva Pharmaceuticals
Job Id: 60702

Company Overview

Teva Pharmaceuticals is a global leader in providing affordable access to essential medicines, with a presence in nearly 60 countries. We are dedicated to improving health for millions around the world through our wide range of generic medications and products, including those on the World Health Organization's Essential Medicines List.

Job Responsibilities

Audit of Bioanalytical Phase of BA/BE Studies
- Ensure that the facilities, personnel, equipment, instruments, protocols, methods, practices, records, and controls comply with relevant GCP and GLP guidelines, protocols, and SOPs.
SOP Review
- Review SOPs, forms, formats, and logbooks of all departments and provide feedback.
Change Control and Deviations
- Review and provide insights on change control and deviations as assigned.
Audit Report Preparation
- Prepare audit reports to ensure compliance with guidelines, written procedures, and regulatory inspections. Ensure user departments adhere to audit report findings.
Method SOP Review
- Review method SOPs as required and ensure they meet the necessary standards.
In-Process Study Audits
- Conduct in-process study audits to confirm compliance with GCP/GLP, protocols, SOPs, and applicable regulatory requirements.
Audit of Raw Data and Bioanalytical Reports
- Audit generated raw data, validation reports, addendums, and bioanalytical reports from method validation, partial method validation, and clinical study sample analysis.
Sharing QA Audited Data
- Share QA audited concentration data with the Biostatistician per business timelines.
Audit of PK and Statistical Output
- Audit pharmacokinetic (PK) and statistical output of clinical studies as needed.
Bio-summary Tables and eCTD Compilation
- Audit bio-summary tables (OGD) and eCTD compilation of clinical studies.
Study Audits and Documentation Review
- Review ongoing study reports and documentation, and issue study-specific audit certificates.
Coordination for Bioanalytical Reports
- Coordinate with user departments and medical writers to finalize bioanalytical and clinical study reports.
Audit Trail Review on LC-MS/MS
- Review the audit trail on LC-MS/MS instruments to ensure compliance.
Specific Audits
- Conduct area-specific audits, system audits, and vendor audits as required.
Audit of Calibration and Qualification Records
- Audit calibration and qualification records for instruments/equipment used in bioanalytical work.
Document Control and Issuance
- Control and issue documents such as SOPs, forms, formats, logbooks, study-specific protocols, validation protocols, and qualification protocols across all departments.

Qualifications

Education:
- B.Pharm, M.Pharm, or M.Sc.
Experience:
- 3-6 years of experience in Bioanalytical Quality Assurance, specifically for BA/BE Studies.

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. We uphold a policy of providing equal employment opportunities regardless of age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin, or any other legally recognized status entitled to protection under applicable laws. We are committed to fostering a diverse and inclusive workplace.

If you are contacted for a job opportunity, please let us know if you require any accommodations during the recruitment and selection process. All accommodation information provided will be kept confidential and used solely to ensure an accessible candidate experience.

Interested candidates are encouraged to apply via Teva Pharmaceuticals’ career portal.

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Quality Analyst I

Job Description

Company Overview

Job Responsibilities

Qualifications

Teva’s Equal Employment Opportunity Commitment

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