Senior Executive - Quality Assurance - Chemical Development Job in Syngene International

JOB DESCRIPTION

Designation: Senior Executive

Job Location: Bangalore

Department: Quality Assurance Chemical Development

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 Purpose:

This role involves in monitoring and reviewing the Quality Management Systems, analytical reports, documents and records.

Job Description:

Key Responsibilities:

• Review and approval of Specifications.
• Handling and evaluation of change control, verification and implementation of the corrective and preventive action.
• Review and approval of Analytical reports and approvals of Certificate of Analysis.
• Preparation, review and evaluation of Quality procedures, SOPs.
• Review and approval of analytical calibrations.
• Review and approval of method transfer protocols.
• Release of Raw Materials(RM)/ Packaging Materials(PM) in SAP.
• Coordinating with the laboratory personnel in handling of deviations,Laboratory incidents, OOS, CAPA.
• Training on newly introduced or modified SOPs.
• Co-ordination and participation during customer/third party cGMP audits, regulatory audits and internal quality audits.
• 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 Science

Technical/functional Skills:

Should be familiar with Analytical testing and Instrumentation.

Should have knowledge in Laboratory Information Systems, Trackwise, E-Document Management System

Experience: 03 06 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.