Junior Manager - Quality Assurance - Chemical Development

Job Description

Designation: Junior ManagerJob Location: BangaloreDepartment: Quality Assurance Chemical DevelopmentAbout SyngeneIncorporated 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 PurposeThis role involves in initial qualification and revalidation activities of facility/Area, equipment, computerized system along with its control systems, and clean utilities.Job DescriptionKey Responsibilities:

• Responsible for GXP requirements while performing Qualification & Validation activity in facility.
• Implementation of computer system validation.
• Coordinate the activities of QA validation team with the efforts of stakeholder departments, ensuring the timely completion of projects and project milestones.
• Review and Approval of URS, impact assessment, protocols & reports for facility/Area, equipment & clean utilities.
• Responsible for revalidation/qualification strategy.
• Ensure Quality Assurance validation oversight during FAT & SAT as per qualification requirements & documentation.
• Ensure execution of DQ where required, IQ, OQ and PQ activity of the new facility/product/process critical equipment along with documentation in place in time.
• Ensuring validation QA oversight while assessing risk/impact on validated state during any facility, clean utilities, equipment related deviations and change controls.
• Preparation & review of QA SOPs related to qualifications & drawings etc.
• Preparation of Master Validation Plan.
• Review and approval of equipment/systems/facility specific SOPs, Protocols & Reports related to Syngene facilities.
• Supporting and facing regulatory/customer audits.
• Review and approval of facility related drawings/layouts (for ex., pressure differential, AHU zoning, area classification, equipment layouts).
• Review and approval of Preventive maintenance of the equipment related procedures of Syngene facility.
• Conducting Vendor/service provider Audits and internal audits
• Provide oversight and ensure training of company and contract personnel who will be executing validation protocols.
• Assists QA validation team members with validation project activities (e.g., reviewing protocols, auditing, executing/reviewing tests, drafting reports, etc.) to ensure timely completion of testing and approved summary reports.
• Ensure QA validation oversight during periodic HVAC, LAF s, BSC s related revalidations.
• Ensure QA validation oversight for Temperature and RH mapping of identified areas and equipment in coordination with user, Engineering and external party if required.
• Handling of quality management system (Change controls, Deviations, CAPA etc.,)
• 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.Sc. / M. PharmTechnical/functional Skills:Should have very good knowledge on Quality Management System, qualification & validations.Experience: 7 - 9 years relevant experienceBehavioral Skills:

• Should have the capability to work in a team and ability to handle demonstrate a good team spirit.
• While possessing a good ability to follow instruction should also demonstrate innovative in his/her approach, good communication skills.
• Should be proactive while working on allotted responsibility.

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 :
impact assessmentquality management systemtroubleshootingquality managementquality assuranceposition managementmanagement system