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Job Description

Designation: Junior Manager Job Location: Bangalore, Biocon Park Department: Quality Assurance -Biologics About Syngene Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation .
• To handle the Inprocess and Finished products team as shift in charge.
• Review of Analytical documents related to Inprocess/Finished products/Stability/Method validations.
• Responsible for preparation of documents such as SOPs, IOPs, EOPs etc.
• Preparation of batch release documents like specifications, STPs with observation data sheet, verification protocols, method transfer protocols etc.
• Handling Internal audits, Client audits and Regulatory Audits pertaining to Biologics Operations Unit.
• Coordinate for Internal Audits in consultation with Internal Quality Audit Team as per the schedule.
• Coordination with cross functional departments on the status/ progress of Audit related CAPA on a weekly basis.
• Tracking follow- up and closure of CAPAs triggered through external audits, internal audits and self-inspections. Provide data and updates on the same to Internal Quality Audit team on a monthly basis.
• Ensuring all time audit readiness and preparation prior to audits.
• Ensuring completion status of action items of CAPAs triggered through observations of previous audits.
• Provide data on status of audit related CAPA progress/closure for Quality Governance Forum.
• Assessment of FDA 483 observation reports and regulatory guidelines against current systems in Syngene.
Key Responsibilities:
• Handling shift and ensuring release of Inprcoess/Finished product samples within TAT and by adhering to compliance norms.
• Review of Analytical documents related to Inprocess/Finished products/Stability/Method validations.
• Guidance to the analysts on good laboratory and analytical procedures.
Educational Qualification: Master of Science / Master of Technology -Biotechnology/Bioprocess Engineering Technical/functional Skills:
• Knowledge on Biologics Manufacturing and testing compliance requirements.
• Subject Matter expert on the Guidelines/regulations pertaining to Biologics.
• Tactful communication.
Experience: 9-12 years of experience in Biopharma manufacturing/testing/compliance/Quality Assurance. Behavioral Skills:
• Aggressive but assertive on task completion.
• High influencing skills to complete the task at hand.
• Ability to provide solutions for complex problems.
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.,

Keyskills :
internal quality auditorconsumer goodscalibrationquality controlinspectioniso