Department Details

Role Summary

Responsible for ensuring compliance of analytical activities with ALCOA++ and GxP requirements through same‑day review of raw data, audit trails, chromatographic sequences, and instrument readiness. Oversees analyst training, qualification, laboratory practices, and resource utilization while supporting investigations (OOS/OOT/deviations), CAPA implementation, and change controls. Accountable for documentation control, software/system configuration, stability study management, cross‑functional coordination, audit participation, and maintaining a protected, compliant Quality Control laboratory environment.

Key Responsibilities

1. Review analytical activities and raw data to ensure compliance with ALCOA++ principles, including logbooks, formats, observation data sheets (ODS), and attached printouts, ensuring proper countersignature, secure filing, and traceability.

- Ensure that analysts hand over complete ODS and associated raw data at the end of each working day.
- Ensure adherence to current GxP requirements and safety standards in the Quality Control laboratory.
- Perform same‑day review of audit trails and instrument-generated raw data for analytical activities.
- Create, review, and manage projects, methods, and system configurations for chromatographic and other QC software systems.
- Conduct online review and locking of chromatographic sequences against prepared sequences on a daily basis.
- Review periodic calibrations, preventive maintenance,



and qualification activities of instruments to ensure system readiness and prevent sequence errors due to review oversight.
- Ensure analysts' compliance with good laboratory practices, including availability and use of dedicated clean trays, pipette stands, desiccators, waste disposal bins, and legible glassware labelling during analysis.
- Ensure retention of glassware until completion of document review.
- Attend and comply with job-related trainings, including online trainings, SOP/IOP trainings, and GxP trainings as per the approved training calendar.
- Plan, monitor, and ensure timely qualification and re‑qualification of analysts well before due dates.
- Complete all assigned trainings and courses in SAP SuccessFactors LMS within stipulated timelines.
- Ensure cleanliness of instruments, timely update of instrument status boards, and prompt review of daily calibrations.
- Release instruments for routine analysis only after completion of review activities.
- Prepare, review, and implement Specifications, STPs, ODS, COAs, and Quality Control SOPs and IOPs in compliance with regulatory requirements.
- Actively participate in laboratory investigations, including OOS, OOT, incidents, and deviations, with a focus on human error reduction and recurrence prevention.
- Supervise optimal utilization of resources within the Quality Control laboratory.
- Ensure timely initiation, review, and closure of change controls, deviations, and CAPAs arising from OOS, incidents, deviations, or other quality events.

Educational Qualifications

Required Education Qualification: MSc.

Required Experience: 10 - 15 years

📌 Assistant Manager (India)
🏢 BIOCON PHARMA
📍 India