Latest Pharma Job Alert! Syngene is Hiring for Drug Substance QMS role | M Pharm Graduates Apply Now
Searching for a rewarding Pharma Job in Quality Assurance? Syngene Careers brings an excellent opportunity for professionals looking to grow in Drug Substance Quality Management Systems. This Pharma Job at Syngene offers exposure to global regulatory compliance, QMS operations, biologics manufacturing support, and advanced quality systems within one of India’s leading research-driven organizations. Candidates exploring Syngene Careers can build strong expertise in CAPA, deviation handling, audits, and GMP-regulated environments.
- Job Title: Drug Substance QMS QA
- Location: Bangalore, Karnataka, India (562158)
About the Company
Syngene is an innovation-led contract research, development, and manufacturing organization offering integrated scientific services from early discovery to commercial supply.
At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and SOPs, in letter and spirit.
Job Description
- Responsible for Drug Substance QMS QA Role
- To review and to assess Change control, Deviation, CAPA, OOS, OOT, Internal Audit, Market complaints & Product Recall
- To prepare QMS trends & QMS metrics
- To conduct the Quality Review Meeting and coordinate with CFT members
- To prepare the QRM slides and presentation with the site team members. Recording the Minutes of the meeting
- Knowledge in the usage of Power BI tools & QMS data, Graphical representation
- Handling of EQMS TrackWise Audit Management
- Handling of the EDMS document management system pertaining tothe Biologics Operations Unit
- Preparation of trends as per the schedule for all QMS elements as applicable
- To perform the regulatory audit observations gap assessment
- To perform the revised guidelines gap assessment
- Follow-up and closure of all QMS elements as applicable
- Contribute to the review of audit reports and compliance reporting
- Preparation of SOP/SOP-E/GP/Specifications/protocols/stan and relevant Annexure
- Plan and schedule analytical activities in the department and ensure compliance with SQDECC parameters
- Any other work allocated by the HOD or the team leader
- Primarily responsible for the Quality Management System activities
- Responsible for the FDA 483’s and gap assessment review
- Responsible for cross-deployment CAPA assessment
- Responsible for the Quality Review Meeting data presentation
- To review and approve the QMS events, i.e., Change control, Deviation, CAPA, OOS & OOT
- To be involved in the investigation of Drug Product-related incidents & market complaints
- Involved in the monitoring of the process through process step verification. Review of the Batch Manufacturing Record to check compliance with the stepwise process execution till written instructions
- Involved in review and approval of documents related to CSV, LIMS, overall qualification activity, protocols, reports, etc.
- Reporting any deviations and discrepancies to the superiors and reporting head. Handling of Deviations and their closure at the right intervals
- Secondary label issuance for FG. Target Monitoring for batch-related process activities
- Adherence to procedural systems, cGMP, data integrity & transparency is maintained within the organization
- Equipment/Instrument Breakdown, Work Order approvals & tracking usage
- Return and verification approval of unused & excess materials
- Involved in Document Control and Document Issuance
- Involved in Archival of Documents
Key Responsibilities
- Review and approval of Change Control, Deviation, CAPA, OOS & OOT
- Preparation of QMS trends, metrics, and audit reporting
- Regulatory audit,s gap assessment, and compliance review
- Conducting Quality Review Meetings and presentations
- Handling TrackWise EQMS and EDMS systems
- Monitoring cGMP compliance and data integrity
- Investigation of Drug Product-related incidents & market complaints
- Review of Batch Manufacturing Records
- Document control, archival, and issuance
Qualifications
Education: M.Pharm / M.Sc / Any Graduate
Skills and Capabilities
- Microsoft Office
- Basic computer skills
- MS Office
- Self-motivated
- Able to communicate in English
Leadership Capabilities
- Must have basic communication skills to interact with other cross functional dept.
