AQA, Associate Manager

Job Description

Designation: Associate Manager Job Location: Bangalore, Biocon Park Department: Analytical 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 . Key Responsibilities: Responsible for Analytical Quality Assurance activities pertaining to Quality Control Biologics (AQA activities of QC Biologics). Educational Qualification: Master of Science / Master of Technology -Biotechnology/Bioprocess Engineering Technical/functional Skills:
• Review and approval of the Analytical testing records and Final Batch release COAs.
• Review and approval of documents related to CSV, LIMS, over all qualification activity, protocols, reports etc.
• Review and approval of Analytical Method validation, Analytical method transfer, Excel validations, Forced degradations - Protocols and Reports.
• Handling & management of Deviations, Laboratory incidents coordinating in identifying the root cause investigations with CAPA identification, approval and the final approvals and closure of QMS documents.
• Review and approval of stability summary and stability reports generated by QC.
• Review & approval of specifications for RM/PM/Consumables/IP/FP of QC Biologics.
• Review and approval of working/lab/impurity/GC standards/ Protocols, COA and reports.
• Verification of Instrument Operating Procedures, IQ/OQ/PQ/DQ of all instruments of QC.
• Coordinating with the laboratory personnel in handling of the customer/client queries.
• Review of all the analytical documents in line with the Standard Operating Procedures.
• Responsible for Track Wise QA approver role for all the applicable QMS.
• Handling, evaluation and approval of change control, verification and implementation of the Corrective and Preventive Actions.
• Review, approval of Equipment/Instrument qualification and CSV documents related to Quality Control- Biologics.
• Handling of customer projects, customer audit CAPAs, and to ensure the documents related to Quality Control are reviewed and approved.
• Responding to queries providing support to customer/regulatory on analytical related documents/requests as per the customer/regulatory requirement.
Experience: 9 to 13 years of experience in Quality control /compliance/Quality Assurance. Behavioral Skills:
• Effective communication skills
• Good Eye for detail
• Good in creating and maintaining relations with cross functional teams for facilitation of work.
• Aggressive but assertive on task completion.
• High influencing skills to complete the task at hand.
• Solution provider: 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 :
salesmiscontinuous improvement facilitationqualitymanagementcustomer relations