We are a leading organization in the pharmaceutical and clinical research sectors, specializing in bioanalytical, clinical trials, quality assurance, and drug safety. Our mission is to uphold excellence in research, innovation, and compliance with global standards.
Job Roles and Responsibilities
1. Analyst – Bioanalytical (LC-MS/MS)
- Responsibilities:
- Perform method development, validation, and study sample analysis.
- Operate equipment like HPLC, LC-MS/MS, and ELISA.
- Compile and analyze data as per SOPs and regulatory guidelines.
- Prepare and archive SOPs, protocols, validation reports, and study reports.
- Ensure compliance with audit findings and regulatory standards.
- Qualifications:
- M.Sc., B.Pharm, or M.Pharm.
- Hands-on experience with LC-MS/MS and bioanalytical methods.
- Knowledge of GLP regulations.
- Preferred Skills: Method development, validation, and regulatory compliance.
2. Analyst – Bioanalytical (ELISA / LBA)
- Responsibilities:
- Develop bioanalytical methods for PK, immunogenicity, and biomarkers.
- Validate methods and perform sample analysis.
- Collaborate with QA for data integrity and report preparation.
- Maintain and calibrate lab equipment.
- Qualifications:
- M.Sc., B.Pharm, M.Pharm, B.Tech/M.Tech in Biotechnology.
- Expertise in ELISA and ligand-binding assays.
- Familiarity with GLP regulations.
3. Clinical Research Associate (CRA) / Clinical Research Coordinator (CRC)
- Responsibilities:
- Monitor clinical trials and ensure compliance with protocols.
- Manage essential documents and resources at study sites.
- Supervise data collection and CRF documentation.
- Conduct source data verification and study closure.
- Qualifications:
- Any Science Graduate.
- 1-3 years of experience in clinical trials.
4. Clinical Trials – QA
- Responsibilities:
- Conduct site selection and clinical trial audits.
- Review subject records, CRF design, and SOPs.
- Issue audit reports and assess CAPA.
- Provide feedback on clinical study reports.
- Qualifications:
- 2-6 years of experience in quality assurance.
- Strong knowledge of GCP guidelines.
5. Drug Safety Associate – MICC
- Responsibilities:
- Handle medical inquiries for pharmaceuticals, devices, and cosmetics.
- Provide accurate information to healthcare professionals and patients.
- Prepare responses based on research and collaborate with internal teams.
- Participate in a 24/7 inquiry handling service.
- Qualifications:
- Degree in Life Sciences, Pharmacy, or Medical Sciences.
- Fluency in English; multilingual skills preferred.
Qualifications and Skills
- Strong educational background in relevant fields (M.Sc., B.Pharm, M.Pharm, etc.).
- Hands-on experience with analytical techniques (e.g., LC-MS/MS, ELISA).
- Knowledge of regulatory and compliance standards such as GLP and GCP.
- Excellent data analysis, communication, and documentation skills.
- Ability to work collaboratively in a fast-paced environment.