Quality Expert Chromatography

6 months ago

Malkajgiri Hyderabad Telangana, India Amogen Pharma Private Limited Full time

As an Executive QC Chromatography and Stability Analyst, you will play a pivotal role in ensuring the quality and stability of pharmaceutical products through chromatographic analysis and stability testing. You will be responsible for performing HPLC and GC analyses, conducting stability studies, and providing analytical support to the Quality Control (QC) department.

**Key Responsibilities**:

- Execute routine chromatographic analyses using HPLC and GC instrumentation to assess the quality and purity of drug substances and drug products.
- Perform stability testing activities, including sample preparation, testing, and data analysis, to evaluate product stability under different environmental conditions.
- Support method development, validation, and optimization efforts for chromatographic assays to ensure robustness, accuracy, and precision.
- Collaborate with QC team members to troubleshoot analytical challenges, investigate out-of-specification results, and implement corrective actions as needed.
- Maintain comprehensive documentation of analytical procedures, results, and observations in accordance with regulatory requirements and internal SOPs.
- Stay abreast of industry trends, advancements in chromatography techniques, and regulatory guidelines related to stability testing and analytical methods.

**Requirements**:

- Bachelor's degree in Chemistry, Analytical Chemistry, or related field.
- 3-5 years of experience in chromatographic analysis, with a focus on HPLC and GC techniques, preferably in a pharmaceutical or biotechnology industry setting.
- Proficiency in method development, validation, and troubleshooting for HPLC and GC assays.
- Familiarity with stability testing principles and regulatory guidelines (e.g., ICH guidelines) is advantageous.
- Strong analytical skills, attention to detail, and ability to interpret chromatographic data accurately.
- Ability to work independently, prioritize tasks, and manage time efficiently to meet project deadlines.
- Excellent communication skills, both verbal and written, with the ability to collaborate effectively with colleagues across departments.
- Ability to work independently, prioritize tasks, and manage time efficiently to meet project deadlines.
- Commitment to maintaining compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) standards.

**Job Types**: Full-time, Permanent

Pay: ₹8,364.50 - ₹48,119.34 per month

**Benefits**:

- Food provided
- Leave encashment
- Paid sick time
- Provident Fund

Schedule:

- Morning shift
- Rotational shift

**Experience**:

- total work: 3 years (required)

Work Location: In person

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