Address
Form of work Providing analytical support for PD activities ensuring compliance to regulatory, group directives, quality requirements, safety standards.
Education / Experience
POST GRADUATE IN ANALYTICAL CHEMISTRY/PHARMACY/ORGANIC CHEMISTRY with Experience: 3-7 years
Technical skills & Competencies / Language
- Expertise for operating/handling of various analytical instruments
- GMP documentation
- Sense of data integrity
- Spoken and written English
Behavioral Competencies
- SuperpowerZ (Responsible, Fast, Lean, Inclusive, Creative, Connected)
KEY ACCOUNTABILITIES
Analytical development:
Analytical method development
Analytical method transfer
Analytical method validation
CMC activity: Sampling & testing of Process water, Raw materials, Intermediates, APIs & Cleaning validation samples
Sending samples to third party/customer
Preparation and approval of CoA
Generation and archival of GMP documents
Preparation of system & operational SOPs using Geode+
Maintaining inventory of laboratory reagents and chemicals
Providing analytical support to pilot plant in case of deviation investigation
Co-ordination with pilot plant & PRD to provide analytical support
Investigation in case of deviation & customer complaint
cGMP: Compliance to current GMP guidelines.
Follow ALCOA principal maintaining GMP data
Compliance to local and international norms (Quality/HSE)
Knowledge of change control and deviation management
Regulatory compliance
Regular Pharmacopoeia and regulatory requirement review
Training of self on quality and HSE systems.
Instrumentation: Operation & calibration of HPLC, GC, HSGC, UPLC, UV, FITR, DSC & other laboratory instruments
Trouble shooting for said instrument
Co-ordination with service provider for repairing and preventive maintenance
Qualification of laboratory instruments
Management of logbooks
Other Complying to HSE Requirements
Identifying and correcting unsafe conditions or behaviours and promptly reporting other potentially hazardous situations.
Carrying out any other assignments or projects as per the instruction of the Dept. Head to meet with the organizational objectives and priorities.
