Job Title: Assistant Manager Drug Substance QMS QA
Job Location: Syngene Unit 3 Bangalore
About Syngene : Syngene ( www. syngeneintl. com ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.
Mandatory expectation for all roles as per Syngene safety guidelines
- Overall adherence to safe practices and procedures of oneself and the teams aligned
- Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards
- Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
- Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
- Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self
- Compliance to Syngene s quality standards at all times
- Hold self and their teams accountable for the achievement of safety goals
- Govern and Review safety metrics from time to time
Core Purpose of the Role:
- Responsible for Drug Substance QMS QA Role
- To review and to carry out the assessment of 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 coordination with CFT members.
- To prepare the QRM slides and presentation with site team members. Recording the Minutes of meeting.
- Knowledge in usage of Power BI tools & QMS data Graphical representation
- Handling of EQMS TrackWise Audit Management
- Handling of EDMS document management system pertaining to Biologics Operations Unit
- Preparation of trends as per schedule for all QMS elements as applicable
- To Perform the regulatory audits 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 HOD or 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 involve in the investigation of Drug Product related incidents & market complaints
- Involve in Monitoring of process through process step verification. Review of Batch Manufacturing Record to check compliance from stepwise process execution till written instructions
- Involve 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 its closure at right intervals
- Secondary label issuance for FG. Target Monitoring for batch related process activities
- Adherence to procedural systems, cGMP, data integrity & transparency maintained within the organization
- Equipment/Instrument Breakdown, Work Order approvals & tracking usage
- Return and verification approval of unused & excess materials
- Involve in Document Control and Document Issuance
- Involve in Archival of Documents.
Role Accountabilities: Accountable for the above-assigned role
Leadership Capabilities: Must have basic communication skills to interact with other cross functional dept.
Syngene Values
All employees will consistently demonstrate alignment with our core values
- Excellence
- Integrity
- Professionalism
Specific requirements for this role
- Experience: 8-13 Years
- Demonstrated Capability: as per the above role
- Education: M. Pharm / M. Sc / Any Graduate
Experience: 8-13 years
Skills and Capabilities: Microsoft Office, Basic computer skills, MS Office, self-motivated, able to communicate in English
Equal Opportunity Employer
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