About this role
Department: Quality control Analytical
Role: QC (Compliance)
Role Summary:
- As a QC Analytical person, the role involves managing samples from receipt to release, ensuring timely analysis and accurate documentation in compliance with GMP/GLP standards. Responsibilities include performing analytical testing, compiling results, and supporting equipment qualification, calibration, and maintenance. The position also requires participation in stability studies, handling deviations and corrective actions, and maintaining training and regulatory records. Additionally, the role supports audit readiness, SOP development, and continuous improvement initiatives to uphold quality systems and regulatory compliance.
Roles & Responsibilities
Responsibiliti es:
- Review of Cleaning records of area, Equipment daily verification/ calibration Data.
- Review of All logbooks of QC Analytical department.
- Review of all data i.e. In process, Drug Substance, Stability studies, Protocols, Raw material, packing material, method validation/verification/transfer data.
- Identify and escalate deviations observed during review.
- To provide issuance of Document numbers to QA.
- To Compile and verify the Data packages of Batch records and submission to QA.
- To prepare Stability Summary report, Trending of Lab incidents, invalids of QC Analytical department.
- Compliance, Audit & Regulatory Support
- Preparation and review of QC Analytical SOPs.
- Review of equipment audit trail and alarms as well as perform data audit trails.
- Ensuring adherence to cGMP, operational SOPs, and regulatory expectations.
- To assist in writing SOP documents, change plan or change records (document revisions) supporting continuous improvement of test procedures and assay sheet design.
Basic Requirements:
- Qualification: Master’s degree in science
- Good verbal and email communication skills
- Attention to detail and strong compliance mindset
- Curiosity to read, learn and working across cross-functional teams
- Basic MS Office: Word, Excel, PowerPoint
- Flexible to work in shifts as per operational requirements.
Life Science Graduate & Post Graduate