Quality Expert Wet Lab Analysis

1 week ago

Malkajgiri Hyderabad Telangana, India Amogen Pharma Private Limited Full time

As a Chemical Characterization QC Analyst, you will be responsible for conducting wet-lab analyses and chemical characterization studies to support quality control activities within the organization. This role requires a strong understanding of QC principles, analytical methodologies, and regulatory requirements.

**Key Responsibilities**:

- Perform wet-lab analyses, including HPLC and other chromatographic techniques, to characterize raw materials, intermediates, and finished products according to established protocols and specifications.
- Conduct chemical identification, quantification, and impurity profiling using analytical instrumentation and wet-lab techniques, ensuring accuracy and reliability of results.
- Execute method validation, method transfer, and method optimization studies for HPLC assays, collaborating with cross-functional teams as necessary.
- Assist in troubleshooting analytical challenges, investigating out-of-specification results, and implementing corrective actions to maintain product quality and compliance.
- Maintain and calibrate analytical instruments, ensuring proper functioning and adherence to cGMP standards and regulatory requirements.
- Document all laboratory activities, experimental procedures, and results accurately and comprehensively in accordance with SOPs and regulatory guidelines.
- Participate in QC team meetings, training sessions, and continuous improvement initiatives to enhance technical skills, knowledge, and efficiency.

**Requirements**:

- Bachelor's or Master's degree in Chemistry, Analytical Chemistry, or related field.
- 3-5 years of experience in analytical chemistry and quality control, preferably in the pharmaceutical or biotechnology industry.
- Proficiency in HPLC instrumentation and chromatographic techniques, with hands-on experience in method development, validation, and troubleshooting.
- Strong understanding of quality control principles, cGMP regulations, and regulatory guidelines (e.g., FDA, ICH) applicable to pharmaceutical products.
- Excellent analytical skills, attention to detail, and ability to interpret and analyze complex data sets accurately.
- Effective communication skills, both verbal and written, with the ability to collaborate with cross-functional teams and convey technical information clearly.
- Ability to work independently, prioritize tasks, and manage time effectively to meet project deadlines in a fast-paced environment.
- Commitment to upholding quality standards, safety protocols, and compliance with SOPs and regulatory requirements.

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

Pay: ₹9,622.99 - ₹21,396.30 per month

**Benefits**:

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

Schedule:

- Day shift
- Morning shift
- Rotational shift

**Experience**:

- total work: 1 year (preferred)

Work Location: In person

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