Assistant Manager - Development Quality Assurance Job in Syngene International

JOB DESCRIPTION

Designation: Assistant Manager

Job Location: Bangalore

Department: Development Quality Assurance

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:

• To ensure Quality Management System elements are tracked.
• To ensure data integrity principles are followed throughout the data life cycle.

Job Description:

Key Responsibilities:

• Preparation and review of Quality Assurance SOPs.
• Review and approval of SOPs/ IOPs/EOPs from user department.
• Review and approval of laboratory instrument / equipment qualification documents.
• Review and approval of Technology Transfer Documents.
• Review and approval of Development Documents.
• Quality review and oversight for Discovery and Development Projects which goes for Regulatory Submission.
• Review and approval of protocols and reports.
• Handling of change control, deviation, Incidents.
• Control of documents and records.
• Issuance of logbooks and Laboratory Note Books.
• Conducting internal and external audits.
• Conduct quality system training to relevant departments.
• Planning and coordination for the customer, certification and regulatory audits.
• Ensure QA records generated are archived on a periodic basis.
• Liaising with User Department for Third Party Archival.
• Responsibilities indicated in the respective SOPs.
• Any other job indicated by the Management / QA
• 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:

• Review and quality governance towards adherence to laid down procedure in analytical testing lab.
• Communicating withstakeholders to identify training needs and mapping out development plans for teams and individuals.
• Collaborate with cross functional team for successful client audits.

Experience: More than 7 years experience in Quality.

Behavioral Skills:

• Ability to collaborate with cross functional team members.
• Assertiveness.
• Conceptual thinking and reasoning.
• Good communication skills.
• Customer centric.

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.