Senior Executive - QA

Role & responsibilities

• Review and evaluation of QC analytical data, including thorough electronic data and audit trail review to ensure data integrity.
• Review of analytical specifications, STPs/analytical procedures, protocols, and laboratory-related SOPs.
• Review of QC laboratory qualification/calibration status of analytical instruments.
• Batch Release Management.
• Hands on analytical experience.
• Review of batch manufacturing and packaging records, including audit trail verification.
• Preparation and Review of APR.
• Oversight and review of QC laboratory activities to ensure adherence to SOPs and quality standards.
• Initiation, investigation, and review of QMS elements such as Deviations, Change Controls, OOS, OOT, and CAPA.
• Review and execution of cleaning validation activities in accordance with regulatory guidelines.
• Support during regulatory inspections and customer audits.

Preferred candidate profile

• Quick learner with excellent communication skills
• Punctual with proven track record of dedication & reliability
• A team player who is equally capable of working alone
• Fluent in both written and spoken English
• Knowledge /Experience in peptides