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Etico Lifesciences Seeks Experienced Formulation AR&D Professional in Hyderabad
Hyderabad – Etico Lifesciences, a pharmaceutical company, has announced an opening for a senior-level position in Formulation Analytical Research & Development (AR&D), focusing on analytical method validation across multiple dosage forms.
Position Overview
The company is recruiting for a specialized role centered on analytical method validation of semi-solids, solids, injectables, and ophthalmic dosage forms. Candidates with experience in Quality Control (QC) validation are also being considered for this position based in Pragathi Nagar, Hyderabad.
Candidate Requirements
The ideal candidate should possess:
Educational Qualification: B.Pharm, M.Pharm, or M.Sc degree
Professional Experience: A substantial 15 years of experience in the pharmaceutical industry
Key Responsibilities
The role encompasses six major areas of responsibility:
Project Management: The selected candidate will handle multiple analytical projects simultaneously, establishing objectives and prioritizing activities according to business needs.
Method Development: Responsibilities include designing, developing, and validating both qualitative and quantitative analytical methods, along with managing batch release testing.
Cross-Functional Collaboration: The position requires providing project management oversight, maintaining timelines, and coordinating with Cross-Functional Teams (CFT) to support recommendations.
Instrument Qualification: The role involves developing and managing instrument qualification procedures, timelines, and software validation priorities.
Quality Assurance: Ensuring all quality work—including records, logbooks, worksheets, and notebooks—meets regulatory and laboratory standards with accuracy and completeness.
Regulatory Compliance: Full compliance with all regulatory, quality, and safety requirements is essential.
Application Process
Interested candidates meeting the qualifications can submit their resumes to: Careers@eticolifesciences.com
FAQ:
1. What types of analytical techniques are commonly used for method validation in multiple dosage forms?
Analytical method validation in semi-solids, solids, injectables, and ophthalmic formulations often employs techniques such as HPLC, UPLC, GC, FTIR, UV-Vis spectroscopy, Dissolution testing, Particle size analysis, and Karl Fischer titration. Each technique is selected based on the critical quality attributes (CQAs) of the specific dosage form.
2. What are the key parameters evaluated during analytical method validation?
Method validation parameters, as per ICH Q2 (R2) guidelines, include:
Specificity
Linearity and range
Accuracy
Precision (repeatability and intermediate precision)
Limit of Detection (LOD) and Limit of Quantitation (LOQ)
Robustness
System suitability testing
These ensure the analytical method produces reliable, reproducible, and regulatory-compliant data.
3. How does AR&D ensure compliance with regulatory standards during analytical operations?
AR&D compliance is maintained through adherence to cGMP, ICH, and 21 CFR Part 11 guidelines. This includes:
Maintaining data integrity (ALCOA principles)
Performing instrument qualification (IQ/OQ/PQ)
Using validated analytical software systems
Ensuring proper documentation control and traceability in all analytical activities.
4. What is the difference between method validation in AR&D and method transfer to Quality Control (QC)?
In AR&D, method validation focuses on establishing the method’s reliability and robustness under controlled R&D conditions.
In QC, validated methods are transferred through a documented method transfer protocol to verify reproducibility in a production or quality environment. Any deviations are investigated and addressed to ensure consistent performance across laboratories.
5. How are analytical instruments qualified and maintained for consistent performance?
Instrument qualification involves a structured approach:
Installation Qualification (IQ): Verifying correct installation.
Operational Qualification (OQ): Confirming the instrument operates as intended.
Performance Qualification (PQ): Ensuring consistent performance under actual working conditions.
Routine preventive maintenance, calibration, and software validation are also conducted to ensure data accuracy and compliance.
