02 Nov
|
Exemed Pharmaceuticals
|
Vadodara
02 Nov
Exemed Pharmaceuticals
Vadodara
Company Description Exemed Pharmaceuticals is a regulatory-compliant, customer-centric pharmaceutical company based in India, recognized as a global leader in its field. Established in 2009 as part of a venture initiated by Mr.
Pranav
Patel, the company has grown steadily with a focus on quality and innovation. Exemed operates two advanced manufacturing facilities dedicated to drug intermediates and specialty chemicals. Its state-of-the-art facilities in Luna and Vapi are certified by US FDA, EDQM, and EU GMP, and the organization is headquartered in Vadodara, Gujarat. Team members join a professionally managed, growth-oriented environment committed to high standards and international markets.
Role Description The Bioanalytical Monitor is a full-time, in office role based in Vadodara, responsible for overseeing bioanalytical activities within regulated pharmaceutical projects. The role includes monitoring bioanalytical studies, ensuring compliance with relevant regulatory guidelines (such as GLP and GCP), and verifying that study protocols and standard operating procedures are correctly implemented.
The Bioanalytical
Monitor will review raw data, chromatograms, and analytical reports for accuracy, completeness, and integrity, and coordinate with laboratory teams and project managers to resolve discrepancies and implement corrective actions. Daily tasks also include preparing monitoring reports, supporting audits and inspections,
contributing to method validation and sample analysis oversight, and collaborating cross-functionally to maintain quality and timelines.
Qualifications
- Strong foundation in bioanalytical methods and techniques, including chromatographic and mass spectrometric analysis, with experience in method validation and sample processing.
- Knowledge of regulatory guidelines and quality systems, such as GLP, GCP, US FDA, EU GMP, and documentation practices for bioequivalence and clinical studies.
- Data review and quality assurance skills, including the ability to evaluate raw data, reports, and laboratory records for accuracy, consistency, and adherence to protocols.
- Project coordination and communication skills to work effectively with cross-functional teams, manage timelines, and provide clear monitoring feedback and reports.
- Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, or a related life science discipline.
- Relevant experience in a bioanalytical laboratory, CRO, or pharmaceutical environment monitoring bioequivalence or clinical studies is preferred.
- Attention to detail, strong analytical thinking, and the ability to work in a structured, process-driven environment.
- Proficiency in basic computer applications and familiarity with laboratory information management systems (LIMS) or similar tools is an advantage.
📌 Bioanalytical monitor (Vadodara)
🏢 Exemed Pharmaceuticals
📍 Vadodara