Prepare for execute the Synthetic R D and collaborative testing projects as per ISO/IEC 17025.
Ensure the projects requirements by Coordinating with the supervisor
Ensure the availability of chemicals, standards and test licenses.
Execute projects per the approved test protocols if assigned.
Responsible for preparation of SOPs, protocols, reports, etc.
Ensure the projects requirements by coordinating with the Purchasing department.
Complete ARD (USP NF CDL) and collaborative testing projects within timelines by coordinating with Manager.
Responsible for preparation of the records and documents.
Ensure that the calibrations of the equipment s are performed as per the schedule.
Prepare, execute and complete IQ/OQ/PQ of new instruments.
Indent the required glass ware, chemicals and columns for the ARD projects.
Maintain GLP implement safety procedures while working in Lab.
Perform other Projects whenever free from ARD activities.
Preparation and planning for ISO 9001 ISO 17025 certification/recertification by participating actively, verification of protocols and related documents and take an active role in the internal as well as external QA audits and address the audit issues in a timely manner.
Participates in USP cross functional teams as appropriate
Required Skills:
Proficient with pharmaceutical testing requirements involving compendial methods for reference materials.
Expert in HPLC and GC analysis and troubleshooting, proficient in other related analytical instrumentation (IR, KF, UV, and thermal analysis techniques etc.).
Knowledge of handling LCMS and GCMS will be added advantage.
Working knowledge of computer applications, such as MS Word and MS Excel are required.
Good interpersonal skills and proven ability to function in a team oriented environment are necessary.
Proven track record of consistently delivering projects on time and with high quality.
Prior experience in a high volume pharmaceutical ARD laboratory or contract pharmaceutical analytical laboratory testing organization is a plus.
Takes personal responsibility for delivery of projects to customers.
General chapter information, Empower and NuGenesis will be preferred.
M.Sc. in Analytical Chemistry / Organic Chemistry, from a well recognized University in India or abroad and required not less than 6 8 years experience in Analytical lab.
Must have hands on experience in working with chemical methods and handling instruments like HPLC, GC, FTIR, UV Visible, wet chemistry, etc. Must have experience with electronic notebook documentation of experimental procedures (LMS) and QMS system.
Good technical writing and verbal communication skills are required.
Good interpersonal skills and proven ability to function in a team oriented environment are necessary. Understanding of GMP / ISO IEC 17025 Guidelines is a requirement
Job Classification
Industry: Pharma, Biotech, Clinical ResearchFunctional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology, Role Category: R&DRole: R&DEmployement Type: Full time
Education
Under Graduation: Any Graduate in Any SpecializationPost Graduation: Any Postgraduate in Any Specialization, MS/M.Sc(Science) in ChemistryDoctorate: Any Doctorate in Any Specialization, Doctorate Not Required