deputy manager

JOB DESCRIPTION

Job Title: Deputy 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
• Responsible for leading the Drug Product shop floor IPQA team
• Responsible for ensuring the online documentation on the shop floor
• Responsible to implement the Contamination Control Strategy at Drug Product Facility 
• Responsible to provide the adequate training to shop floor team on the sterility assurance of the drug product.
• Responsible for ensuring the compliance of DP manufacturing area
• 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
• To review and approve the process validation protocols, reports
• To review and approve the Mediafill simulation protocols and reports
• To review and approve the cleaning validation protocols, reports
• To review and approve the Hold time study protocols, reports
• To ensure the Line Clearence at all stages of drug product manufacturing, Product change over verification of Equipment Qualifications, Calibrations, PM, Cleaning, Sterilization and Breakdown status,
• To review and ensure the aseptic practices & interventions monitoring
• Develop the IPQA team to ensure the online documentation in shop floor
• 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 at all stages of batch.
• To perform inprocess sampling, finished product sampling, control samples and stability samples collection.
• 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.
• Responsible for the Vendor Management and Materials release based on the requirements. 
• 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

1. 
   
2. Experience: 9-15 Years
3. Demonstrated Capability: as per the above role
4. Education: M.Pharm / M.Sc / Any Graduate

Experience: 9-15 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.