Job Description

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Career Opportunities: Junior Manager - QMS Engineer 1 1 (55097)

Requisition ID 55097 - Posted - India

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JOB DESCRIPTION

Designation: Junior Manager - QMS Engineer
Job Location: Bangalore
Department: Engineering and Maintenance

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:

• Investigation Report writing (methods of Root cause analysis: brainstorming, WHY WHY analysis).
• Understanding of writing the corrective & Preventive Action, knowledge to apply SOP for the sections where reference is required for justifying the types of errors & then concluding with all the evidences.
• Preparation of QMS reports weekly & monthly.
• Timely closure of Quality Management System, Corrective Action Preventive Action, Deviations, CCFs.
• Training Coordinator
• Technical investigation report writing
• Reports on QMS requirements
• Documentation support for audits readiness.
• Ensuring the timely calibration of instruments related procedure, planner of Syngene facility by the Instrumentation team.
• Ensuring of preventive maintenance of the equipment related procedure of Syngene facility by the maintenance team.
• Writing Standard operating procedures (SOPs), End of procedure (EOPs), Intensive Office Procedures (IOPs) as per the units &in lines to corporate guidelines.
• Preparation and review of Engineering & Maintenance SOPs pertaining to Business Unit function
• Issuance of logbooks and review of executed logbooks for completeness.
• Issuance of format and protocol numbers.
• Physical verification of CAPAs in the facility triggering from audits/Quality Management System
• Handling of TrackWise for follow-up and closure of all QMS elements, whichever is applicable.
• Training of employees on various aspects like Good Documentation and aseptic 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:

• BE/B.Tech
• Masters in Science with exposure in Quality Department of Bio-Pharma can also be considered.

Technical/functional Skills:

• Technical report writing (English grammar)
• Timely checks on planners, CAPA, CCF\'s, Deviations, Observations.
• Good Understanding of Investigation report writing.

• Experience in handling CFT concerns for any revision in GENSOP & block specific SOP\'s

Experience:

• 4-8 years of QMS experience

Behavioral Skills:

• Good communication skill
• Ability to work under pressure
• Problem-solving skills
• Teamwork skills

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.

Syngene International