Associate Manager - Development Quality Assurance - It Job in Syngene International

JOB DESCRIPTION

Designation: Associate Manager

Job Location: Bangalore

Department: Development Quality Assurance - IT

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 ensuring Electronic Records & Electronic Signature compliance is adhered to and ensure electronic data generated are ALCOA plus compliant.

Job Description:

Key Responsibilities:

• The IT- Development Quality Assurance person should review data generated across all experiment phases.
• ALCOA + principles should be reviewed in Electronic Lab Note (eLN).
• Instrument generated raw data and audit trails shall be reviewed on a periodic basis as per defined schedule.
• Track and ensure that the data backup and restoration procedure is followed in compliance.
• To monitor the date and time for all laboratory instruments during monthly verification through spot check.
• Review and approval of Privilege Access Request Form (ARF) for applications software.
• Review and approval of Work Instructions for User Account(s) Management
• Review and approval of Work Instructions for User Roles Privileges Matrix.
• Ensure 21CFR part 11 compliance.
• 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.
• Ensure environment, health, and safety (EHS) measures are imparted via training and adhered within the team.

Educational Qualification: Masters in Science

Technical/functional Skills:

• Experience in electronic data management in a similar industry. Hands on experience of Computer system Validation and 21 CFR part 11 Compliance is mandatory.
• Review and quality governance towards adherence to laid down procedure in analytical testing lab.
• Collaborate with cross functional team implementation of ER ES requirements.

Experience: 9 to 12 years

Behavioral Skills:

• Should have good communication skill and should be a good team player.
• 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 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.