Assistant Manager

JOB DESCRIPTION

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.

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

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

1. Experience: 8-13 Years
2. Demonstrated Capability: as per the above role
3. 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

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.