
Advanced Analytical Method Specialist
2 days ago
Indus Pharma Pvt Ltd seeks a professional to validate analytical methods. The successful candidate will be responsible for planning, executing, and documenting method validations ensuring accuracy, precision, specificity, linearity, robustness, LOD, LOQ, and other critical parameters.
The role involves reviewing and approving validation protocols and reports in compliance with ICH Q2 R1, USP, and other regulatory requirements. Additionally, the candidate will coordinate with teams for smooth tech transfer and validation support.
- Plan and execute method validations for raw materials, in-process samples, finished products, and cleaning validation.
- Review and approve validation protocols and reports in compliance with ICH Q2 R1, USP, and other regulatory requirements.
- Cordinate with teams for smooth tech transfer and validation support.
The ideal candidate will have a strong background in analytical chemistry, with hands-on experience with HPLC, GC, UV, and other analytical techniques. A minimum of 5-7 years of experience in QC, with at least 2-3 years specifically in AMV for sterile injectable formulations, is required. Educational qualifications include B Pharm, M Pharm, or MSc in Analytical Chemistry or equivalent.
Key responsibilities include:
- Validating analytical methods for accuracy, precision, specificity, and linearity
- Ensuring compliance with regulatory requirements such as ICH Q2 R1 and USP
- Cordinating with teams for tech transfer and validation support
- Maintaining records of method validations and reports
To succeed in this role, you should have excellent problem-solving skills, attention to detail, and strong communication skills. Experience with HPLC, GC, UV, and other analytical techniques is also essential.
RequirementsWe are looking for a highly skilled analytical chemist to join our team. If you have a passion for analytical chemistry and a desire to work in a fast-paced environment, we encourage you to apply.
The ideal candidate will have:
- A strong background in analytical chemistry
- Hands-on experience with HPLC, GC, UV, and other analytical techniques
- Minimum 5-7 years of experience in QC
- At least 2-3 years specifically in AMV for sterile injectable formulations
- B Pharm, M Pharm, or MSc in Analytical Chemistry or equivalent
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