Assistant Manager - Quality Control - Api Job in Syngene International

JOB DESCRIPTION

Designation: Assistant Manager

Job Location: Bangalore

Department: Quality Control - API

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.

Job Description:

Key Responsibilities:

• Responsible for the implementation and management of Laboratory Information Management Systems (LIMS), Interfacing of laboratory instruments, CDS & Electronic Lab Notebook (ELN) in quality control laboratories.
• Responsible to track Laboratory Information Management Systems (LIMS) & Electronic Lab Notebook (ELN) project status to ensure project action items are completed within stipulated timeline.
• Responsible to prepare applicable protocol and SOP `s related to LIMS & ELN process.
• Responsible to write the applicable test scripts & execution of the same during validation process.
• Responsible to ensure all the activities performed as per CSV compliance.
• Responsible to review all the documents related to LIMS & ELN process.
• Responsible to maintain up to date knowledge on new features and functionalities in the LIMS application.
• Responsible to work with cross-functional teams in order to ensure smooth and seamless rollout of LIMS &ELN project.
• Must have experience in the qualification, validation and implementation of LIMS and ELN application in QC.
• Responsible for management of static data, develop new LIMS &ELN objects and configuration of LIMS templates as per business need.
• Responsible to ensure validation of configured LIMS objects.
• Responsible to ensure user acceptance testing is completed for newly developed LIMS objects as applicable.
• Responsible to provide user training on LIMS process flows and support to business on troubleshooting of LIMS and ELN issues.
• Responsible to provide recommendations for future upgrades and versions of LIMS application.
• Manage additional responsibilities as situation demands.
• 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: Maters in Science

Technical/functional Skills:

Should possess strong knowledge in implementing Laboratory Information Management Systems (LIMS), Electronic Lab Notebook (ELN) and instruments interface in Quality Control.

Experience: 09 12 years

Behavioral Skills:

• 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 strong in Data Integrity.
• 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.