Senior Officer, Quality Control

RXinsider LTD.; India; On-site; INR 1,000,000 - 1,500,000; Full time

Job summary

RXinsider LTD. is seeking an Executive – Quality Control to ensure smooth laboratory operations in a regulated setting. You will review raw data, release COAs, manage LIMS, calibrate instruments, and coordinate investigations related to OOS, OOT, and CAPA, while upholding SOPs and GMP requirements.

The role involves training analysts, maintaining quality systems, supporting audits, and ensuring compliance with regulatory guidelines including USFDA, WHO, MHRA, and GMP. 7 years in QC is expected.

Qualifications

• Masters in Chemistry with 7 years in Quality Control in a regulated lab.
• Experience of working in cGMP/GLP environments and regulatory guidelines.
• Expertise in handling deviations, CAPA, OOS, OOT, incidents and investigations.
• Proficient in data review, certificate of analysis release and documentation control.
• LIMS management, instrument calibration/maintenance, and SOP adherence.

Responsibilities

• Follow and ensure compliance with cGMP, GLP and safety norms.
• Implement and ensure SOPs, STPs, GTPs and lab procedures.
• Review raw data and release COA.
• Maintain QC lab documentation and online data.
• Monitor calibration schedules for instruments.
• Handle incidents, deviations, OOS, OOT and CAPA closure.
• Coordinate investigations related to analytical incidents and deviations.
• Prepare and update SOPs, protocols, test plans and stability documents.
• Manage LIMS activities including master data creation, review and training.
• Register and manage reference standards, instruments and columns in LIMS.
• Train analysts on LIMS processes and lab practices.
• Support qualification activities for LIMS modules and instruments.
• Ensure monthly electronic data verification and data backup.
• Monitor analyst evaluations and lab performance.

Skills

QC operations

Instrument maintenance

LIMS management

CAPA & investigations

Documentation

Communication & training

Regulatory knowledge

Education

M.Sc. Chemistry

Tools

LIMS software

Analytical instruments

Job description

Job Description

The Executive – Quality Control is responsible for ensuring smooth laboratory operations in compliance with cGMP, GLP, and regulatory requirements. The role includes handling analytical activities, reviewing raw data, maintaining laboratory documentation, instrument calibration and maintenance, LIMS management, and release of COA. The candidate should coordinate investigations related to OOS, OOT, deviations, incidents, and CAPA, while ensuring timely closure and compliance. The position also requires training analysts, maintaining quality systems, supporting audits, and ensuring proper implementation of SOPs and laboratory procedures.

Key Responsibilities

• Follow and maintain cGMP, GLP, safety norms, and company policies.
• Ensure implementation and compliance of SOPs, STPs, GTPs, and laboratory procedures.
• Review completed raw data and release Certificate of Analysis (COA).
• Maintain all QC laboratory documentation, records, and online raw data monitoring.
• Review and monitor calibration schedules for all laboratory instruments.
• Handle laboratory incidents, deviations, OOS, OOT, and CAPA closure within timelines.
• Coordinate investigations related to analytical incidents and deviations.
• Preparation, review, and updation of SOPs, protocols, test plans, and stability documents.
• Manage LIMS activities including master creation, review, troubleshooting, and user training.
• Registration and management of reference standards, working standards, instruments, and columns in LIMS.
• Conduct analyst training on current updates, LIMS processes, and laboratory practices.
• Support qualification activities for LIMS modules and analytical instruments.
• Ensure monthly electronic data verification and backup data verification.
• Monitor analyst evaluations and laboratory performance.Undertake any other responsibilities assigned by QC Head / Department Head.

Required Skills

• Strong knowledge of Quality Control laboratory operations.
• Experience in handling analytical instruments and maintenance activities.
• Good knowledge of LIMS management and troubleshooting.
• Expertise in handling deviations, CAPA, OOS, OOT, incidents, and investigations.
• Strong documentation and review skills.
• Good communication, training, and team coordination skills.
• Knowledge of regulatory requirements including USFDA, WHO, MHRA, and GMP guidelines.

Education

• Master's degree M. Sc. - Chemistry

Experience

• 7 years

Specialized Knowledge: Licenses: