Trainee/Research Associate - Analytical Research & Development

Contract Pharmacal Corp India Pvt Ltd; Ahmedabad District; On-site; INR 700,000 - 1,300,000; Full time

Job summary

Contract Pharmacal Corp India Pvt Ltd is seeking to maintain regulatory compliance by bridging stability testing with quality controls across R&D and commercial manufacturing scale operations.

The role covers stability protocols design, document control, and instrument calibration, ensuring ALCOA+ data integrity and coordination with the USA team. Strong analytical skills and English communication are essential for success in this research-driven environment.

Qualifications

• Strong analytical and problem-solving skills.
• Good understanding of pharmaceutical analytical techniques.
• Excellent written and verbal communication skills in English.
• Ability to communicate with the USA team on day-to-day work activities.

Responsibilities

• Stability Protocols (ICH Q1A - Q1F): Designing and managing stability protocols for exploratory R&D and final commercial batches, with temperature/humidity criteria.
• Document Control: Manage SOPs, Batch Records, and analytical protocols under audit-ready archiving with ALCOA+ data integrity.
• Instrument Calibration: Owns Master Calibration Schedule; manage qualifications (DQ/IQ/OQ/PQ) for systems like HPLC and GC; handle OOC lifecycle investigations.

Skills

Analytical thinking

Problem-solving

Pharmaceutical analytics

English communication

Written communication

Team collaboration

Job description

Role & responsibilities

This Job Description defines the core role for tasked with maintaining regulatory compliance under ICH Quality Guidelines. The position uniquely bridges the technical requirements of stability testing with operational quality controls. The role spans technical accountability across research and development (R&D) workflows and active commercial manufacturing scale operations.

Key Responsibilities Covered in the Documentation :

• Stability Protocols (ICH Q1A - Q1F): Designing and managing stability protocols using advanced matrixing and bracketing techniques for both exploratory R&D and final commercial batches, optimizing storage criteria (temperature/humidity matrices), tracking testing intervals, and evaluating shelf-life trends.
• Document Control: Managing the life cycle of Standard Operating Procedures (SOPs), Batch Records, and analytical protocols under secure, audit-ready archiving frameworks adhering to ALCOA+ data integrity principles.
• Instrument Calibration: Details ownership of the Master Calibration Schedule, managing analytical hardware qualifications (DQ/IQ/OQ/PQ) for systems like HPLC and GC, and handling Out-of-Calibration (OOC) lifecycle investigations. Perform routine internal and external calibrations on core pharmaceutical laboratory instrumentation using primary, certified reference standards.

We're Looking For:

• Strong analytical and problem-solving skills
• Good understanding of pharmaceutical analytical techniques
• Excellent written and verbal communication skills in English
• Ability to communicate with the USA team on day-to-day work activities
• Good communication and documentation skills
• Eagerness to learn, collaborate, and work in a research driven environment
• Positive attitude with a willingness to take ownership and work effectively in a team