Quality Control Technician Iii - Tapi

3+ years

Not Disclosed

Gwalior

10 Dec. 27, 2024

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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
Company: TAPI (Teva Active Pharmaceutical Ingredients)

Company Overview:
TAPI is a global leader in the supply of Active Pharmaceutical Ingredients (APIs), offering an extensive portfolio of over 350 products. The company serves 80% of the top 50 global pharmaceutical companies, with a rich history spanning more than 80 years. With state-of-the-art facilities in Israel, Italy, Hungary, the Czech Republic, Croatia, Mexico, and India, TAPI leads the industry through its experience, expertise, and exceptional customer service. The company is committed to ongoing investment in research and development, ensuring timely introduction of new products to the market.

Role Overview:
The Quality Control Analyst will be responsible for ensuring compliance with quality standards and maintaining audit readiness 24/7. This position requires expertise in HPLC and Empower software, and a strong understanding of chemistry principles. The role involves conducting various analytical tests on raw materials, finished goods, and intermediates, supporting internal and external audits, and adhering to cGMP, GLP, and safety guidelines. The position also involves calibration of instruments, maintenance of laboratory areas, and ensuring timely processing of samples.

Key Responsibilities:

Maintain 24/7 audit readiness and ensure compliance with regulatory standards.
Operate HPLC and Empower software for testing and documentation.
Participate in internal, external, and regulatory audits.
Ensure full participation in training related to CAPA (Corrective and Preventive Actions).
Initiate and investigate laboratory incidents, including LIR (Laboratory Investigation Reports), OOS (Out of Specification), OOT (Out of Trend), and borderline results.
Coordinate with the team leader/manager to prioritize tasks according to plant needs.
Ensure proper housekeeping, cGMP, GLP, and safety guidelines are followed in the laboratory.
Perform sampling and analysis of raw materials, finished goods, intermediates, and cleaning samples.
Record results in analytical sheets, QA forms, LIMS, and ensure adherence to data integrity norms.
Conduct analytical tests according to the monograph and SOPs.
Calibrate and verify laboratory instruments.
Maintain reserved samples rooms, chambers, autoclaves, and incubators.
Assist in preparing departmental documents, including STPs and SOPs.
Ensure timely sampling of finished products, raw materials, and intermediates, and coordinate sending samples for external analysis.
Maintain records of chemicals and reconcile standards.
Assist in managing stock records and ensure proper labeling.

Qualifications and Experience:

Education: Bachelor’s or Master’s degree in Chemistry or related field.
Experience: Minimum 3 years of experience in quality control within the pharmaceutical industry.
Skills:
- Proficient in HPLC and Empower software.
- Strong knowledge of basic chemistry principles.
- Familiarity with laboratory practices, cGMP, GLP, and safety guidelines.
- Ability to investigate and report incidents like OOS, OOT, and LIR.
- Strong attention to detail and organizational skills.
- Ability to manage multiple tasks and meet deadlines.

Teva’s Equal Employment Opportunity Commitment:
Teva Pharmaceuticals is an equal opportunity employer and is committed to creating a diverse and inclusive workplace. The company ensures that all candidates are treated equally without discrimination based on age, race, gender, disability, or any other legally protected status. If you require accommodations during the recruitment process, Teva will provide support to ensure an accessible experience.

Apply today to be part of a global leader in the pharmaceutical industry!

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Quality Control Technician Iii - Tapi

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