Officer /Sr. Officer - QC

Roles and Responsibilities

• Perform analysis and troubleshooting of laboratory instruments like HPLC, GC, UV /IR spectrophotometer, KF, and Dissolution, etc
• Perform calibration / qualification of laboratory instruments.
• Take quality improvement initiatives for compliance and output in line with new technology and ensure regulatory benchmarks and expectations are met.
• Drive root-cause analysis and CAPAs for all non-conformities, OOS, and OOTs.
• Responsible for all-time audit readiness and participate in the regulatory inspections in the laboratory.
• Responsible for self-capability building through various assigned training programs.
• Responsible for analysis of process validation samples, finished products and stability samples.

Desired Candidate Profile

• Should have experience in the pharmaceutical Industry preferably in Oral Solid Formulations and have regulatory exposure to USFDA/ MHRA/EU/TGA etc.
• Should have excellent verbal & written communication skills.
• Should have analytical and problem-solving skills.
• Should be able to work independently and in a team.
• Should be able to take initiatives and proactively seek quality solutions through an emphasis on continuous improvement.
• Should have analytical technique and document writing skills w.r.t. finished goods, stability, raw materials, packing materials, and validation samples for oral solid products.
• Should have exposure to developed GLP policies and quality culture.
• Should understand electronic data of various software applicable in laboratory