Junior Manager

JOB DESCRIPTION Job Title Junior Manager - Drug Product Manufacturing QA Job Location Syngene Unit 3 Bangalore About 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 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 Product Manufacturing Quality Assurance To prepare review process validation protocols reports To prepare review Mediafill simulation protocols and reports To prepare review cleaning validation protocols reports To prepare review Hold time study protocols reports To provide Line Clearence at all stages of drug product manufacturing Product change over verification of Equipment Qualifications Calibrations PM Cleaning Sterilization and Breakdown status Aseptic practices verification monitoring and review Intervention monitoring and trending of routine non routine interventions To perform AQL checks after 100 visual inspection Visual inspection kit preparation and management of visual inspectors qualification To perform inprocess checks during routine product manufacturing To perform inprocess sampling finished product sampling control samples and stability samples collection Involve in Monitoring of process through process step verification Reviewal 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 Verification of Instrument Operating Procedures of all instruments across all CFTs Preparation of URS Impact Risk assessments and other necessary documents Review approval of Equipment Instrument qualification documents related to Drug Product Plant Facility To initiate change controls wherever necessary and ensure to complete the tasks initiated Handling evaluation and approval of change control verification and implementation of the Corrective and Preventive Actions 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 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