Quality Control Analyst I

5-6 years

Not Disclosed

Gwalior India

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 Control Analyst I
Date: Jan 31, 2025
Location: Gwalior, India, 477117
Company: Teva Pharmaceuticals
Job Id: 58745

Company Overview:

Teva Active Pharmaceutical Ingredients (TAPI) is the leading international supplier of active pharmaceutical ingredients (APIs). With a broad portfolio of over 350 API products, TAPI serves as the go-to global supplier for APIs, supporting 80% of the top 50 global pharmaceutical companies. With over 80 years of trusted history in the generic API industry, TAPI is recognized for its experience, expertise, technologies, and exceptional customer service. The company operates globally, employing more than 4,000 professionals at 14 sites, with state-of-the-art production facilities in Italy, Hungary, the Czech Republic, Croatia, Israel, Mexico, and India.

Position Overview:

The Quality Control Analyst I will be responsible for performing various quality control activities in the laboratory, ensuring compliance with Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and safety guidelines. The position requires exposure to High-Performance Liquid Chromatography (HPLC), active participation in audits, and collaboration with the team to achieve plant objectives. The role involves the analysis of raw materials, finished goods, and intermediates, as well as documentation and reporting of laboratory investigation reports (LIR), out of specification (OOS), and other quality control metrics.

Key Responsibilities:

Audit Readiness:
- Maintain 24×7 audit readiness by ensuring laboratory procedures and activities are compliant with internal, external, and regulatory audits.
HPLC Exposure:
- Utilize High-Performance Liquid Chromatography (HPLC) techniques to perform analytical testing and support laboratory activities.
CAPA Training:
- Ensure full participation in Corrective and Preventive Action (CAPA) training programs.
Deviation Investigation:
- Initiate and investigate Laboratory Investigation Reports (LIR), Out of Specification (OOS), Out of Trend (OOT), and borderline results. Report findings to the in-charge.
Documentation Support:
- Assist in sharing the required Quality Control (QC) documents with Regulatory Affairs (RA) and other relevant departments.
Team Coordination:
- Collaborate with the team leader and manager to determine priorities in line with the plant’s needs and ensure timely completion of tasks.
Laboratory Compliance:
- Ensure compliance with housekeeping, cGMP, GLP, and safety guidelines in the laboratory.
Sampling and Analysis:
- Perform sampling and analysis of raw materials (RM), finished goods (FG), intermediates, and cleaning samples as required. Ensure timely result entry in analytical sheets, QA forms, LIMS, and online documentation as per data integrity norms.
Analytical Testing:
- Conduct analytical tests according to the specified monographs and Standard Operating Procedures (SOPs).
Calibration and Verification:
- Perform calibration and verification of laboratory instruments to ensure they are operating according to required standards.
Sample Management:
- Maintain reserved samples room, autoclaves, incubators, and other storage areas to ensure compliance with quality standards.
Documentation Assistance:
- Assist in the preparation and maintenance of department documents, including Standard Testing Procedures (STPs), SOPs, and other relevant documentation.
Labeling and Documentation:
- Ensure the timely sampling, approval, and rejection of labels for finished products, raw materials, and intermediates.
Stock Management:
- Maintain stock records for chemicals and reconciliation of standards used in quality testing.
Safety CAPA:
- Ensure that safety-related CAPA (Corrective and Preventive Actions) are addressed and implemented as per company guidelines.
5S Implementation:
- Ensure adherence to 5S standards in the QC department to maintain a clean and organized work environment.
Efficiency Programs:
- Support analysis reduction and QC efficiency enhancement programs to improve laboratory processes.
Other Duties:
- Perform any other tasks as assigned by the QC Manager or Group Leader – QC.

Experience & Qualifications:

Educational Requirements:
- Bachelor’s or Master’s degree in Science (preferably in Chemistry or a related field).
Experience:
- Minimum of 5 years of experience in Quality Control in a pharmaceutical or related manufacturing environment.

Teva’s Equal Employment Opportunity Commitment:

Teva Pharmaceuticals is committed to providing equal employment opportunities to all employees and applicants, irrespective 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. Teva fosters a diverse and inclusive workplace. If you require any accommodations during the recruitment process, please inform us, and we will ensure an accessible candidate experience.

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

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