24 Oct
|
EduRun Group
|
India
24 Oct
EduRun Group
India
Company Description EduRun Group is an IT services and consulting organization focused on driving business growth through innovation and strategic technology management. The team partners closely with clients to optimize operations and deliver sustainable success in a rapidly evolving digital landscape. EduRun Group designs cutting-edge software solutions and digital experiences that strengthen brands and support measurable results.
Guided by a mission to help clients bring great products to market, the company aims to set new industry standards through innovative solutions, strong user experiences, and empowering businesses for a digital future.
Role Description The US Pharma – Quality Control (QC) / Analytical Development Scientist role at EduRun Group is a remote position focused on supporting pharmaceutical clients with high-quality analytical and quality oversight. In this role, the scientist designs, develops, and optimizes analytical methods for drug substances and products, ensuring accuracy, precision, and compliance with regulatory expectations. Day-to-day activities include executing QC testing, reviewing and interpreting analytical data, preparing and approving documentation such as test protocols, reports, and standard operating procedures, and supporting method validation and transfer.
The scientist collaborates with cross-functional teams to resolve deviations, investigate out-of-specification results,
and implement corrective and preventive actions, while contributing to continuous improvement of quality systems and laboratory practices.
Qualifications
- Quality Control expertise, including laboratory testing, data review, and method development for pharmaceutical products.
- Quality Assurance and Quality Management skills to support compliant processes, documentation, and continuous improvement initiatives.
- Strong knowledge of Good Manufacturing Practice (GMP) guidelines and the ability to apply them in day-to-day analytical and QC activities.
- Experience with Quality Auditing, including internal audits, readiness assessments, and support for regulatory or client inspections.
- Advanced understanding of analytical techniques (e.g., HPLC, GC, spectroscopy, dissolution) and applicable pharmacopeial standards.
- Bachelor’s or Master’s degree in Chemistry, Pharmaceutical Sciences, or a related scientific discipline; higher degree is an advantage.
- Experience in US pharmaceutical or biopharmaceutical environments, with familiarity in FDA regulations and ICH guidelines.
- Strong documentation, data integrity, and organizational skills, with attention to detail in work from home settings.
- Ability to collaborate effectively with cross-functional teams and communicate technical information clearly in writing and verbally.
📌 US Pharma- Quality Control (QC) / Analytical Development Scientist (India)
🏢 EduRun Group
📍 India