Senior Executive - Quality Assurance - Gcp Job in Syngene International

JOB DESCRIPTION

Designation: Senior Executive

Job Location: Bangalore

Department: Quality Assurance-GCP

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 handling and supporting the maintenance of following electronic systems and other paper based systems.
• E-Quality Management Systems (Track Wise).
• E-Document Management Systems (Open text Documentum).
• E-Learning management systems (SAP Success factors).
• Document and data archival systems and its associated applications as per the procedures and support the Quality System lead for improvements in consultation with GCP Quality Head as required by the organization and its corporate quality policies.
• Support the Quality Systems(QS) lead and ensure the site is compliant with Quality Management Systems, the quality regulations and standards required for clinical development operations and ultimately is audit ready.
• 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: Master's in Life sciences / Pharmaceutical sciences /Biotechnology or related technical discipline.

Technical/functional Skills:

• Good knowledge in Quality Management System.
• He/she will work incollaboration with a QS lead toensure the QMS elements are following ICH GCP /Schedule Y and the required quality policiesof the organization.
• Maintain electronic QMS /DMS/LMS and content management / qualitysystems-specific tools such as SAP LMS, Track wise and Documentum.
• Collate data for quality /operational metrics preparation using MS Excel.

Experience: 2 6 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 able to work in team and flexible for working in shifts.
• 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.