Senior Research Associate - AR&DJob; Description Business: PPL Digwal Department: PTS Location: Digwal Job Overview: To perform AR&D; actives as per GMP & Safety Travel Requirements: NA Reporting Structure: Reports to Research Scientist - AR&D; (Service) Key Stakeholders: Internal: QC, QA, SCM & Safety External: NA Experience:
- 4-8 Year Experience in manufacturing (API) as per Pharma Manufacturing GMP requirements.
- Responsibilities for Internal Candidates Key Roles & Responsibilities 1. Capable to handle independent projects 2. Analytical testing support to PDG synthetic group.
- Coordinate with QA regarding method transfer, CCF and investigation reports. 4.
Experience of handling of HPLC, GC, Potentiometer, Polarimeter instruments.
- API Stability knowledge.
- Capable to handle analytical method development, Implementation, Validation as per requirement.
- Should have experience of Analytical method transfer to QC. 8.
Experience of making documents like method transfer protocol & report, method validation protocol & report, method development report, specification, standard test procedure etc.
- Should aware about GLP practices and 21 CFR part-11.
- Keep the work area clean and the laboratory under controlled temperature.
- Calibrate the instruments according to the master calibration schedule and follow GLP and SOPs.
- Understand the safety and environmental aspect.
- Maintain the reagents and standardize the volumetric solutions as per schedule.
- Maintain the laboratory journals and instrument log books online.
- Ensure compliance to Hazardous waste and chemical management.