JUNIOR MANAGER

Syngene International

Bangalore, Karnataka
Permanent
Full-time

2 days ago

JOB DESCRIPTIONJob Title: Junior Manager - Analytical Quality AssuranceJob Location: Syngene Unit 3 BangaloreAbout Syngene : 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 spiritMandatory 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 Analytical Quality Assurance Role
To review all analytical testing records related to Drug substance and Drug Product
Experience with all types of QC instruments used for biological testing & drug product testing
Responsible for QC instruments audit trail review in the laboratory
Responsible for RM, PM, Consumables materials release in LIMS & SAP
Responsible for inprocess test, finished product test, reports review and release in LIMS
Responsible for review of specifications
Responsible for Microbiology related testing review i.e. BET, Bioburden & Sterility test
Responsible for OOS & OOT review in the trackwise
To ensure the good documentation practices and ensure the data integrity compliance
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.
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 roleLeadership Capabilities: Must have basic communication skills to interact with other cross functional dept.Syngene ValuesAll 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 yearsSkills and Capabilities: Microsoft Office, Basic computer skills, MS Office, self-motivated, able to communicate in EnglishEqual Opportunity EmployerIt 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.

Syngene International

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