Executive / Senior Executive - Analytical Development (ADL)

Why This Role Matters

Analytical Development plays a decisive role in ensuring pharmaceutical products meet regulatory, quality, and stability standards before reaching patients. Robust method development and validation directly support formulation innovation, regulatory submissions, and commercial manufacturing.
At Corona Remedies Limited, the Analytical Development team supports product innovation across women’s healthcare, cardio-diabeto, pain management, and urology segments while maintaining strict cGMP and GLP compliance.

Job Description

Corona Remedies Limited is expanding its Analytical Development Laboratory (ADL) team for its Gujarat manufacturing operations (including Bhayla plant). The role involves method development, validation, and transfer of analytical procedures for pharmaceutical formulations in a regulated environment.
The selected candidate will collaborate closely with Formulation R&D and Quality Control teams to ensure accurate analytical support during development, scale-up, and commercial production stages.

Key Features of the Role

• Exposure to advanced analytical instrumentation
• Involvement in method development and validation as per ICH guidelines
• Participation in regulatory documentation (CTD/DMF support)
• Cross-functional collaboration with R&D and QC
• Opportunity to work in a growing formulation-focused organization

Responsibilities

• Develop, validate, and verify analytical methods for assay, dissolution, and related substances
• Operate instruments such as HPLC, UPLC, GC, UV, FTIR, and Dissolution Apparatus
• Prepare and review analytical protocols and reports
• Maintain COA, CTD, DMF, and related documentation
• Ensure compliance with cGMP, GLP, and ICH guidelines
• Support analytical method transfer to QC for commercial production
• Investigate and resolve analytical deviations and issues
• Perform stability sample analysis
• Assist during audits and regulatory inspections
• Ensure data integrity and proper documentation practices

Required Qualifications

• 2–8 years of experience in Analytical Development
• Hands-on experience in method development and validation
• Strong exposure to chromatographic techniques
• Experience in regulated pharmaceutical environments

Educational Requirements

• M.Sc
• Master of Pharmacy
• Bachelor of Pharmacy

Experience and Skills

• Strong knowledge of ICH guidelines
• Expertise in HPLC/UPLC/GC method development
• Experience in dissolution method optimization
• Familiarity with regulatory documentation (CTD/DMF)
• Good problem-solving and analytical skills
• Strong documentation and compliance mindset
• Ability to collaborate with cross-functional teams

Salary Insights

• ₹4,00,000 to ₹12,00,000 per annum (CTC), depending on experience
• Industry-standard benefits including health insurance and incentives
• Growth opportunities within Analytical Development and Regulatory functions

Company Overview

Corona Remedies Limited is a leading pharmaceutical company with a strong presence in women’s healthcare, cardio-diabeto, pain management, and urology segments. With advanced manufacturing facilities in Gujarat and Himachal Pradesh, the company emphasizes innovation, regulatory compliance, and high-quality formulation development.

FAQs

Q: Is method development experience mandatory?
Yes, hands-on experience in method development and validation is preferred.

Q: Will the role involve regulatory documentation?
Yes, preparation and review of CTD/DMF-related analytical documents are part of the responsibility.

Q: Is experience in a regulated environment required?
Yes, exposure to cGMP/GLP-regulated setups is important.

Application Tips

• Mention instruments handled and methods developed
• Highlight experience with ICH-compliant validation
• Include exposure to CTD/DMF documentation
• Quantify number of methods validated or transferred