QC-ADL

QC-ADL

Candidate 02 (M/F)

Experience Require 02 to 04 year

Note: Priority API Experience only

Job Responsibilities

• Develop and optimize analytical methods for API intermediates and raw materials.
• Perform analytical method validation verification and method transfer.
• Conduct testing using HPLC GC UV KF FTIR and other analytical instruments.
• To provide support and lead the investigation in case of any failure w.r.t any experiment(s) or any plant support activity
• Prepare analytical protocols reports specifications and related documentation.
• Ensure compliance with GMP GLP SOPs and ALCOA data-integrity requirements.
• Support stability studies and regulatory/customer audits.
• Maintain instruments laboratory records and good laboratory practices.
• Coordinate with QA QC R&D Production and Regulatory departments.
• To Prepare SOP STP Specifications Worksheet Protocol etc.

Required Skills:

Analytical method development Analytical method optimization Analytical method validation Analytical method verification Method transfer HPLC GC UV KF FTIR Analytical instrumentation Investigation of analytical failures Plant support activities Preparation of analytical protocols Report writing Specification preparation GMP compliance GLP compliance SOP adherence ALCOA data-integrity compliance Support stability studies Support regulatory audits Support customer audits Instrument maintenance Laboratory records maintenance Good laboratory practices Cross-functional coordination SOP preparation STP preparation Specification documentation Worksheet preparation Protocol preparation