Deputy Manager - Quality Assurance Formulation

Job Description

Designation: Deputy ManagerJob Location: BangaloreDepartment: Quality Assurance - FormulationsAbout 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.Job Purpose Group leader for Qualification & Validation Parenteral/Injectable and formulation OSD manufacturing and packing facility. Ensure qualification and compliance of facility and equipment for liquid injectable & PFS.Job Description Key Responsibilities: Responsible for Qualification and validation of equipment, instrument, Media fill, process, cleaning, HVAC, Water for injection, Steam, Clean in Place (CIP), Steam in Place (SIP), autoclave, filtration and sterility assurance for manufacturing and packing of Injectable manufacturing facility for small molecules & large molecules (biologics) products. Responsible for review of QMS activities like change control, Deviation, Investigations, Market complaints, validation protocols, CAPA, APQR as per need. Implementation and review of Standard operating procedure for system, operational & Equipment. Guide for preparation and review of Batch Manufacturing Record, Batch Packing Record, Media fill record etc. Responsible for loan license or contract manufacturing site activity. Qualify the sites for loan license or contract manufacturing. Review of Quality Agreements. Handling of recall and market complaint. Release of product to the market. Review and approval of batch record, QMS such as OOS, deviation, change control. Notify to the Syngene regulatory. Qualification of the vendor for LL site. Verify the activity at LL sites as per regulatory guideline. Possess the knowledge and exposure to environment, health, and safety (EHS) practices. 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: M. PharmTechnical/functional Skills: Should have hands of experience for Vial filling & PFS filling for liquids, lyophilized products and Cartridge filling line. Should have expertise in review and guide the team for qualification activities like URS, FAT, DQ, IQ, OQ, PQ of equipment/instrument for small volume parenteral and sterility assurance qualification such as media fill, leak test, steam sterilization, terminal sterilization etc. Should have knowledge and experience for technology absorb from development scale to pilot scale.Experience: 12-15 years relevant experienceBehavioral Skills: Must demonstrate the commitment & dedication towards the work has been assigned and willing to take new challenges from management based on need.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 :
batch manufacturingsterility assurancesmall moleculeschange controllegislative relationsanimal healthcontract manufacturingcontrolled environmentsconsumer goodsmarket complaintspilot projects