To ensure the projects requirements by coordinating with the Group Leader.
To involve in project execution, method development and validation of USP/ NF/FCC projects.
To ensure the knowledge on different drug products handling and samples preparations.
Provided effective technical and scientific expertise regarding drug substance and drug product analytical development
Engage in project planning, execution, method development and validation of projects according to set standards as USP general chapters, guidelines, SOPs and protocols.
Ensure the project updates are provided to the supervisor on regularly.
To coordinate with Group Leader to complete the USP/ NF/FCC projects within timelines.
Responsible for preparation and review of SOPs, protocols, reports etc.
Responsible for review of the records and documents.
To ensure that the calibrations of the equipment are performed as per the schedule.
Responsible for preparing, executing, and completing IQ/OQ/PQ of new instruments.
To indent the required glass ware, chemicals, and columns for the USP/NF/FCC projects.
To maintain GLP safety procedures while working in Lab.
Basic Qualifications
Master s Degree in Chemistry with 3-5 years of experience. Possess a fine understanding of USP/NF/FCC monographs/general chapters/general notices.
Exposure to GMP/GLP/QMS environment and documentation procedures and champions the data integrity.
Should be capable of performing analytical method developments and method validations using modern techniques and protocols.
Good analytical skills in handling method development and Validations for Food ingredients and food products.
Should have exposure to GMP/GLP environment and documentation procedures. Awareness of ISO/IEC 17025 is desirable.
Preferred Qualifications
Master s Degree in Chemistry (Analytical / Organic) or Pharmaceutical Sciences with 3-5 years of experience.
Excellent technical writing and oral communication skills required.
Must be able to communicate effectively with diplomacy and enthusiasm.
Technical and analytical skills required including the ability to interpret technical information.
Must have hands on experience in working with chemical methods and handling instruments like HPLC, UHPLC, LC-MS, GC, GC-MS, IC, ICP-OES/MS, FTIR, UV-Visible.
Should have fair understanding of GLP regulations and exposed to external regulatory audits.
Job Classification
Industry: Pharma, Biotech, Clinical Research Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology, Role Category: R&D Role: R&D Employement Type: Full time
Education
Under Graduation: Any Graduate in Any Specialization Post Graduation: Any Postgraduate in Any Specialization Doctorate: Doctorate Not Required