Job highlights
Skills Required: . Valuable English verbal communication skills . Proficiency with MS Office . .
Qualification: MSc Chemistry/BPharma Job Brief: Responsible for overall administration and oversight of quality control, quality assurance, and quality improvements at the testing laboratory.
Job Responsibilities:
Regularize the QC activities as per cGMP requirements.
Ensure regulatory and Pharmacopeia compliance for lab activities.
Review hybrid and electronic data for IPQC and FG analysis.
Perform analytical method validation, handle OOS (Out of Specification) and OOT (Out of Trend) results.
Possess knowledge about IMS systems, including ISO 9001:2015, ISO 14001:2015, OHSAS 18001:2007, and cGMP.
Demonstrate expertise in QC instruments such as HPLC, UV-Visible spectrophotometry, DT instrumentation, ICP,
K/F, and melting point testing.
Plan and execute various validations, including process validation, cleaning validation, water validation, HVAC validation, and environmental validation.
Coordinate with QC staff, RD, commercial, and production teams for quality and dispatch-related activities to ensure timely deliveries.
Resolve troubleshooting issues related to QC activities.
Provide training to subordinates and implement 21 CFR Part 211 and 111 with data integrity (Part-11) compliance.
Skills Required:
Positive English verbal communication skills
Proficiency with MS Office