The Role
Performs analytical method development, validation, transfer, and routine testing for oral solid dosage formulations. Uses HPLC, GC, dissolution, UV-Visible, and FTIR instruments; conducts stability studies; prepares protocols, reports, specifications, SOPs, and testing procedures. Ensures cGMP, GLP, data integrity, and regulatory compliance; maintains laboratory and instrument records; investigates OOS, OOT, and deviations; and collaborates with formulation, quality, and regulatory teams during projects, audits, and inspections.
Summary Generated by Built In
Job Description
· Perform method development, method validation, method transfer, and routine analytical activities for OSD formulations.
· Conduct analysis using HPLC, GC, UV-Visible Spectrophotometer, Dissolution Apparatus, FTIR, and other analytical instruments.
· Prepare analytical protocols, reports, specifications, SOPs, STPs, and related documentation.
· Execute stability sample analysis and support product development activities.
· Ensure compliance with cGMP, GLP, Data Integrity, and regulatory requirements.
· Maintain laboratory records, logbooks, and instrument calibration/qualification documentation.
· Investigate OOS, OOT, and laboratory deviations as per approved procedures.
· Coordinate with Formulation Development, QA, QC, and Regulatory Affairs teams for project execution.
· Participate in audits and regulatory inspections as required.
Required Skills:
· Hands-on experience with HPLC and dissolution testing.
· Knowledge of analytical method validation and stability studies.
· Understanding of ICH guidelines, cGMP, and GLP requirements.
· Good documentation and report-writing skills.
· Proficiency in MS Office applications.
Preferred Candidate Profile:
· Experience in OSD pharmaceutical formulation analysis.
· Good analytical and problem-solving skills.
· Ability to work independently and within cross-functional teams.
Skills Required
- Hands-on experience with HPLC and dissolution testing
- Knowledge of analytical method validation and stability studies
- Understanding of ICH guidelines, cGMP, and GLP requirements
- Good documentation and report-writing skills
- Proficiency in Microsoft Office applications
- Experience in oral solid dosage pharmaceutical formulation analysis
- Good analytical and problem-solving skills
- Ability to work independently and within cross-functional teams
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The Company
What We Do
CORONA Remedies Limited is an Ahmedabad-based pharmaceutical company founded in 2004. It develops, manufactures, and commercialises innovative, value-added, evidence-based medicines addressing unmet health needs. Its portfolio focuses on chronic-care and specialty therapeutic areas, including women’s healthcare and pain management. The company operates manufacturing facilities in Gujarat and Himachal Pradesh and aims to improve health outcomes through quality products and research.
