Job Title: Drug Substance QMS QA
Company: Syngene International Ltd.
Location: Bengaluru, Karnataka, India – 562158
Division: Essential Functions
Job Type: Full-Time
Experience Required: 3–6 Years
Education: M.Pharm, M.Sc., or any graduate in Life Sciences, Pharmacy, or a related discipline
About Syngene
Syngene International Ltd. is an innovation-led contract research, development, and manufacturing organization (CRDMO) that provides integrated scientific services from early discovery to commercial manufacturing. The company partners with global pharmaceutical, biotechnology, and healthcare organizations to accelerate drug discovery, development, and supply.
Headquartered in Bengaluru, India, Syngene delivers high-quality research and manufacturing solutions while maintaining strong compliance with global regulatory standards and quality systems.
Job Summary
Syngene is seeking an experienced professional for the role of Drug Substance QMS QA to support Quality Management System (QMS) activities within the organization. The position involves managing quality systems related to drug substance manufacturing, ensuring compliance with regulatory standards, and supporting continuous quality improvement initiatives.
The role requires expertise in handling quality events such as change controls, deviations, CAPA, OOS, and OOT investigations while coordinating with cross-functional teams to ensure timely closure and regulatory compliance.
Key Responsibilities
Review and assess quality management system events including change control, deviations, CAPA, out-of-specification (OOS), and out-of-trend (OOT) investigations.
Manage internal audits, regulatory observations, market complaints, and product recall assessments in accordance with regulatory requirements.
Prepare QMS trend analysis reports and maintain QMS performance metrics for management review.
Coordinate Quality Review Meetings with cross-functional teams and prepare presentations and documentation related to quality management activities.
Prepare Quality Risk Management (QRM) presentations and document meeting minutes for site quality discussions.
Utilize data visualization tools such as Power BI for graphical representation of QMS data and performance metrics.
Manage electronic quality management systems including TrackWise for audit management and QMS documentation.
Maintain electronic document management systems (EDMS) related to biologics and drug substance operations.
Conduct gap assessments for regulatory audits, updated guidelines, and compliance requirements.
Ensure timely follow-up and closure of QMS actions and corrective measures.
Support preparation and review of audit reports and regulatory compliance documentation.
Draft and review quality documents including SOPs, guidelines, protocols, specifications, and related annexures.
Monitor process compliance through batch record review and process verification activities.
Investigate drug product incidents and market complaints and coordinate corrective actions with relevant departments.
Review and approve documents related to computer system validation (CSV), laboratory information management systems (LIMS), equipment qualification, and validation protocols.
Report deviations, discrepancies, and quality issues to supervisors and ensure timely resolution and documentation closure.
Support document control processes including issuance, management, and archival of quality documents.
Monitor equipment breakdown reports, approve work orders, and track equipment usage documentation.
Manage secondary labeling issuance and monitor batch process activities for quality compliance.
Ensure adherence to cGMP, data integrity requirements, and organizational transparency standards.
Required Skills and Competencies
Strong knowledge of pharmaceutical Quality Management Systems and regulatory compliance requirements.
Experience managing quality events including deviations, CAPA, change control, OOS, and OOT investigations.
Understanding of regulatory standards including cGMP, quality risk management, and audit readiness.
Experience with electronic quality management systems such as TrackWise and EDMS platforms.
Knowledge of data reporting and visualization tools including Microsoft Excel and Power BI.
Strong documentation, analytical, and organizational skills.
Effective communication skills to collaborate with cross-functional teams within quality and manufacturing environments.
Experience Required
Candidates should possess 3–6 years of experience in pharmaceutical quality assurance or quality management systems, particularly within drug substance manufacturing, biologics operations, or regulated pharmaceutical environments. Experience handling QMS processes, regulatory audits, and compliance management is highly preferred.
Syngene Core Values
All employees at Syngene are expected to demonstrate alignment with the organization’s core values:
Excellence
Integrity
Professionalism
Equal Opportunity Statement
Syngene International Ltd. is an equal opportunity employer committed to providing fair employment opportunities to all individuals regardless of age, gender, race, disability, religion, nationality, or any other protected characteristic under applicable law. The company also provides reasonable accommodations for qualified individuals with disabilities during the recruitment process.
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