Syngene International Ltd
Designation: Junior Manager
Job Location: Bangalore
Department: Quality Assurance - GMP - Formulations
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.
This role involves in line clearance during Batch change over and Product Change over and conducting cGMP inspections across the manufacturing plant and supporting area.
Responsible in issuance of Batch Numbers, Batch Manufacturing Records, Packing and Dispatch records.
Review of Master, Executed Batch Manufacturing Records, Packing and Dispatch records.
Approving the Master batch documents.
In process Product Quality Monitoring.
Logging, Review, Evaluation and Closure of Change Control, Deviation, Customer complaint and CAPA raised.
Investigation of Deviation and Customer Complaint.
Review of calibration, qualification and validation reports.
Filing and Maintenance of Quality Documents/Records.
Dispatch inspection and Clearance.
Monitoring of dispensing and other relevant warehouse activity.
Vendor qualification of raw materials, packing materials, consumables, contractors engaged in manufacturing, testing and providing other relevant services pertaining to the cGMP manufacturing with respect to vendor questionnaire verification, vendor audit and compliance report verification for approval.
Approval of vendors by desktop and site audits (as required).
Inspection of Raw material (RM), packing material (PM) and manufacturing consumables for any damage/discrepancy possible during receipt, storage, dispensing and handling of these materials in Warehouse.
Review and approval of SOPs pertaining to Formulation Unit, Warehouse and Materials Management.
Support and review of Warehouse related qualification documents.
Co-ordination and participation during customer/third party cGMP audits, regulatory audits and internal quality audits.
Handling of the SAP related activities related to Batch number creation, Quality info record, MDG code approval for FG/SF, ECN generation and Batch release.
Issuance of Format numbers, Log books, Operating Procedures.
Co-ordination and participation during Internal Audit and Review of Internal Audit Reports.
To ensure implementation and propagation of all EHSS norms so as to create safe working environment.
Responsible for the monitoring and review of Quality Management System, Documentation and records of Formulation Development Center (FDC).
Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety.
Attend training on environment, health, and safety (EHS) measures imparted company.
Educational Qualification: Masters in Pharmacy
Knowledge on current regulatory requirements.
Knowledge and experience in handling Quality Management System.
Should have worked in Oral Solid Dosage forms.
Experience: 6 - 9 Years experience
Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team.
Good speaking-listening-writing skills, attention to details, proactive self-starter
Ability to work successfully in a dynamic, ambiguous environment.
Ability to meet tight deadlines and prioritize workloads.
Ability to develop new ideas and creative solutions.
Should be a focused employee.
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.
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