The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity Excellence manifests in our core value of Passion for Quality through our more than 1,300 hard-working professionals across twenty global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.
Post : Scientist IV/III , Verification Programs - Documentation Specialist
Brief Job Overview
This is a non-supervisory technical position responsible for conducting onsite Good Manufacturing Practice (GMP) facility audits and reviewing ingredient and dietary supplement quality control manufacturing (QCM)/Chemistry and Manufacturing Controls (CMC) documentation for products submitted into the USP Verification Programs (VER).
Job Description
The Documentation Specialist-Scientist III/IV has the following responsibilities :
• Review audit and QCM/CMC corrective action responses from VER participants and assess compliance with GMP and VER program requirements and provide assessment reports..
• Review QCM/CMC documentation for ingredients and dietary supplements, API (Active Pharmaceutical Ingredients), excipient, dietary ingredients submitted by VER participants.
• Prepare timely QCM/CMC product documentation review reports, listing observations/nonconformities.
• Prepare, review, and approve laboratory test protocols.
• Conduct GMP site audits, review audit reports, and assess compliance with GMP and VER program requirements.
• Audit dietary supplements, API, excipient, dietary ingredient manufacturing sites, and contract testing laboratories.
• Coordinate with lab staff on testing requirements and project status.
• Provide support and review laboratory investigations and deviations to ensure documentation accuracy.
• Review and update VER SOPs, participant manuals, and other documents.
• Assist VER lab scientists in conducting verification analytical work, ensuring compliance with test protocols.
• Work with VER staff at USP – USA and other USP sites.
Candidate Profile
The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:
Scientist-IV :
• Master’s degree in science area (Chemistry, Pharmacy) and a combination of skills and experience in the pharmaceutical or related industry, preferably working in Analytical Lab, Analytical reviewer role/Quality Assurance in API or formulations
• A minimum of 8-10 years of experience in Quality, including developing and implementing a Quality Management System.
Scientist-III :
• Master’s degree in science area (Chemistry, Pharmacy) and a combination of skills and experience in the pharmaceutical or related industry, preferably working in Analytical Lab, Analytical reviewer role/Quality Assurance in API or formulations
• A minimum of 6-8 years of experience in Quality, including developing and implementing a Quality Management System.
Must have :
• Regulatory & GMP Expertise : Strong understanding of cGMPs (21 CFR Part 111, 117, 210 & 211), ICH, FDA regulations, WHO and industry standards like ISO, USP etc.
• QMS & Documentation Skills : Proficiency in SOPs, CAPA, deviation handling, change control, batch record review, and data integrity principles.
• Strong written and verbal communication skills, including well-developed interpersonal skills used to influence the behavior of others and the ability to provide candid feedback at all levels.
• Ability to prioritize, manage time well, multitask and troubleshoot.
• Working knowledge of MS Word, PowerPoint, Excel etc.,
Additional Desired Preferences
Desired preferences are to showcase any additional preferred levels of expertise to perform the role. Reminder: any items listed in this section are not requirements nor disqualifies for candidate consideration.
• A certificate from the American Society for Quality (ASQ) as a Certified Quality Auditor (CQA) is optional.
• Trained in internal/external audits, supplier qualification, inspection readiness, and risk-based auditing approaches.
• Familiarity with analytical methods, product specifications, and testing standards for dietary supplements, its ingredients, excipients and Active pharmaceutical ingredients.
• Sharp eye for detail, critical thinking, problem-solving mindset, and unwavering commitment to quality and integrity.
Additional Information
Experience : 6-8 years
Qualification : M.Pharm, MSc
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Verification Programs
Req ID : SCIEN002897
End Date : 31st August 2025
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