Senior Executive - Quality Control (Bioanalytical Lab)

About Sun Pharma and Role Overview

At Sun Pharma, we empower our employees to "Create your own sunshine" by nurturing growth, encouraging ownership of one's career, and fostering a supportive work community. We believe in continuous improvement with a culture that promotes self-drive, leadership, and collaboration.

Role Responsibilities

• Conduct thorough quality control reviews to ensure departmental activities comply with SOPs, study protocols, GLP, GCP, quality standards, and regulatory guidelines.
• Evaluate operations across projects, processes, and facilities within bioanalytical/bioequivalence studies, including pharmacokinetic and statistical components.
• Perform interim assessments of laboratory activities to maintain quality standards.
• Review raw data from method validation and BA/BE studies for accuracy, fullness, integrity, and adherence to guidelines.
• Assess method validation reports and BA/BE study reports for consistency with underlying data and proper study execution.
• Verify pharmacokinetic and statistical data compliance with SOPs, protocols, and regulatory mandates.
• Develop and implement corrective and preventive actions (CAPA) based on Quality Assurance audit findings.
• Prepare, update, and maintain departmental SOPs aligning with regulatory and internal quality requirements.
• Oversee documentation control for raw data forms, laboratory notebooks, and departmental logbooks.
• Serve as the Department Training Coordinator by conducting inductions, organizing ongoing training for staff, and maintaining training records.
• Review assessment and qualification documents of contract service providers.
• Support regulatory processes by providing scientifically sound responses to queries regarding bioavailability and bioequivalence reports.
• Respond strategically to observations from regulatory inspections and audits related to bioequivalence studies.
• Monitor outsourced studies at CROs, ensuring compliance with protocols and regulatory requirements, including data and report reviews.
• Ensure strict adherence to Environmental, Health, and Safety (EHS) policies and guidelines.

Required Skills and Competencies

• Trained in GCP, GLP, and GDP with practical experience in bioanalytical data production or quality control review.
• Demonstrated career stability, strong time management capabilities, effective cross-functional coordination, and proficient communication skills.
• Expertise in data review and quality control within a bioanalytical laboratory setting.

Educational and Experience Requirements

• Master's degree in Pharmacy with a specialization in Quality Assurance (M.Pharma QA).
• Minimum of 4 years’ professional experience in related roles.

Additional Information

Sun Pharma values your success and well-being, offering comprehensive benefits and growth opportunities. This job description outlines general duties and is subject to change or adjustment by the employer based on operational needs and employee experience.