Senior Executive, Quality Control

Description:

This role involves performing complex routine and non-routine analytical testing on various pharmaceutical materials and products using a wide range of analytical techniques (Simple: HPLC, UPLC, GC, Dissolution, UV-Vis, FT-IR, Karl Fischer etc. and Sophisticated: LCMS, GCMS, XRPD, ICP-MS). Key responsibilities include independently performing method verification, transfer, and validation, conducting stability studies, and operating, maintaining, calibrating, and troubleshooting analytical instrumentation, including sophisticated equipment.The role requires meticulous documentation following GDP and ALCOA principles, preparing reports and Certificates of Analysis, and managing laboratory samples according to SOPs. A strong emphasis is placed on quality and compliance, strictly adhering to cGMP, GLP, and company procedures, identifying and investigating OOS/OOT/atypical results, and implementing CAPAs.The role will also be responsible for laboratory maintenance, safety protocols, waste disposal, equipment calibration, and inventory management. Additionally, the role involves continuous improvement activities such as training junior analysts, providing feedback on methods, staying updated with regulations, and participating in training programs.

Essential Functions:

• Perform routine and non-routine testing of pharmaceutical samples using techniques such as HPLC, GC, and LC-MS, while supporting method validation and troubleshooting.
• Operate, calibrate, and maintain analytical instruments, ensuring proper functionality and assisting with equipment qualifications.
• Accurately record test data in compliance with GDP and ALCOA principles, and prepare reports, CoAs, and related documentation
• Manage sampling, logging, storage, and disposal of materials, including stability sample activities as per protocols
• Ensure compliance with cGMP, GLP, and SOPs/ promptly reporting any OOS, OOT deviations and laboratory incidents/ supporting investigations & CAPA actions
• Maintain a clean and safe laboratory environment, handle chemicals responsibly, and monitor equipment and inventory
Mentor junior analysts, contribute to process improvements, stay current with regulatory updates, and participate in training programs.

Additional Responsibilities:

• To ensure destruction of solid and liquid samples which are unused/ left over after analysis. Co-ordination with other departments for sending samples for outside laboratory testing.
• Responsible for the analysis & documentation of Raw-materials and packaging materials.
• Responsible and participate to perform the investigation for Quality issues like OOS, OOAL, Incident and deviations during laboratory activities.
• Responsible for the preparation and standardization of volumetric solutions/reagents and to maintain related documents adequately.
• Responsible for the preparation, handling & management of working/reference standards.
• Responsible for the preparation of SOPs and laboratory related documents.
• To ensure that documentation is done contemporaneously and in the legible manner.
• Responsible to perform analytical method transfer and analytical method verification of Raw material. Management & planning of samples to be analysed in quality control laboratory.
• Responsible to supervise quality control laboratory activity.
• Any other activities/tasks assigned by HOD

Education:

• Bachelors Degree (BA/BS) B. Sc. - Required
• Bachelors Degree (BA/BS) B. Pharm - Preferred
• Master Degree (MS/MA) M. Sc. - Preferred
• Master Degree (MS/MA) M. Pharm - Preferred

Experience:

• 6 years or more in 6-12 years

Skills:

• Analytical testing expertise and evaluation skills - Advanced
• Handling of simple analytical Instruments and Interpretation of Resulting Data - Advanced
• Handling of sofisticated analytical Instruments and Interpretation of Resulting Data - Advanced
• Laboratory Instrument qualification, Calibration & Maintenance - Advanced
• Quality Control & Compliance - Advanced
• Documentation & Data Integrity - Advanced
• Troubleshooting & Problem-Solving - Proficient
• LIMS Operation & Data Management - Advanced
• QMS Documentation (OOS, OOT, Incident) - Proficient
• Stability Study Documentation - Proficient
• Method Validation & Verification - Proficient
• Knowledge of Regulatory Guidelines - Proficient
• Good Manufacturing Practices (GMP) & Good Laboratory Practices (GLP) Knowledge - Proficient

Specialized Knowledge: Licenses: