QC Analyst at Teva Pharmaceuticals – Chemistry Apply
Quality Control Analyst I
Date: Oct 17, 2024
Location: Gwalior, India, 477117
Company: Teva Pharmaceuticals
Job Id: 58745
Who we are
TAPI is the leading international supplier of active pharmaceutical ingredients (APIs). With the industry’s broadest portfolio including over 350 API products, we are the go-to global supplier for APIs, supporting 80% of top 50 global pharmaceutical companies. We are proud of our reliable history in the generic API industry dating back over 80 years, and the fact we are considered to be one of the most trusted API suppliers enables TAPI to lead the industry, based on our experience, expertise, technologies, and exceptional customer service.
Our employees are at the core of our success. Headquartered in Israel, TAPI employs more than 4,000 professionals at 14 sites worldwide. Our state-of-the-art production facilities are located in Italy, Hungary, the Czech Republic, Croatia, Israel, Mexico, and India. Our significant ongoing investment in R&D generates a steady flow of APIs, enabling timely introduction of new products to market.
How you’ll spend your day:
- 24 × 7 audit readiness.
- Participation in internal, external, and regulatory audits.
- Ensure 100% participation in training against CAPA’s.
- Responsible for initiation and investigation on LIR, OOS, OOT & borderline results and reporting them to the in-charge.
- Support sharing required documents from QC to RA/other requirements.
- Determine team priorities in accordance with the plant’s needs, while coordinating with the team leader/manager.
- Follow up on housekeeping, cGMP, GLP, and safety guidelines in the laboratory.
- Sampling and analysis of RM/FG/intermediates/cleaning samples based on requirement and result entry in analytical sheet, QA form, LIMS, and online documentation as per data integrity norms.
- Perform analytical tests according to the monograph and SOP.
- Responsible for calibration and verification of instruments.
- Maintain the reserved samples room and chambers/autoclaves/incubators.
- Help in the preparation of documents related to the department (like STP’s, SOP’s, etc.).
- Ensure the sampling of finished products, raw materials, intermediates, and sending samples to outside laboratories for analysis.
- Ensure sampled, approved, and rejected labels are timely as required.
- Responsible for maintaining the stock record of chemicals and reconciliation of standards.
- Responsible for maintaining safety CAPA.
- Responsible for maintaining 5-S in QC.
- Ensure online documentation (based on requirement) as per data integrity norms and raise awareness among the team against data integrity.
- Support analysis reduction/QC efficiency enhancement programs.
- Any other job assigned by the Manager – QC Manager or group leader – QC.
Your experience and qualifications:
- Bachelor/Master of Science.
- Minimum five years of experience.
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