Quality Control Technician

4 days ago

Gajraula, India TAPI Full time

**Company Description**
At TAPI, we’re not just a company—we’re a community committed to advancing health from the core. As the world’s leading supplier of active pharmaceutical ingredients (APIs), we partner with 80% of the top 50 global pharmaceutical companies. With a legacy spanning over 80 years and a portfolio of more than 350 products, as well as custom CDMO services, we’re shaping the future of health worldwide.

Our strength lies in our people—a team of over 4,200 professionals across 13 state-of-the-art facilities in Italy, Hungary, the Czech Republic, Croatia, Israel, Mexico, and India. Together, we innovate, solve problems, and deliver excellence. Join us and be part of a mission that transforms lives.

**Key Responsibilities**:

- Perform analysis of **stability samples** and **working standard qualification** as per defined procedures and pharmacopeial monographs.
- Operate and maintain analytical instruments, ensuring smooth function and troubleshooting following GLP standards.
- Maintain accurate documentation of **methods**, **specifications**, **logbooks**, **certificates**, and **stability reports**, including archiving data.
- Monitor stability studies in accordance with **ICH Q1** guidelines.
- Conduct **analytical method validation** activities as per **ICH Q2** standards.
- Initiate **LIR/OOS** investigations for any deviations or gaps related to SOPs or monographs during routine operations.
- Ensure qualifications and calibrations of all analytical instruments within the stability section.
- Comply strictly with **laboratory safety procedures** during daily activities.

**Minimum Required Skills**:

- Solid understanding of **Quality Control procedures.**:

- Strong knowledge of **GMP (Good Manufacturing Practices)** and **GLP (Good Laboratory Practices).**:

- Hands-on expertise with **HPLC**, **GC**, **KF**, **Auto titrator**, and **Vacuum oven operations.**:

- Ability to handle instrument troubleshooting and follow documentation protocols.

**Qualifications** Experience Level**: 4+ Years
**Industry Experience**: API Experience is required
**Qualification**: B.Sc. / M.Sc. in Chemistry or B. Pharmacy
**Additional Information** Make Your Mark with TAPI

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