Junior Manager - Quality Assurance - Biologics Job in Syngene International

JOB DESCRIPTION

Designation: Junior Manager

Job Location: Bangalore

Department: Quality Assurance Biologics

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 Quality Assurance activities pertaining to Biologics manufacturing unit (In-process QA activities of Biologics Manufacturing Plants).

Job Description:

Key Responsibilities:

• Review of manufacturing documents (SOPs, EOPs, IOPs and Technology transfer documents) pertaining to Biologics function.
• Review of master batch records and executed batch records (BMR/PDR).
• Review of process validation, cleaning validation and hold time protocols/reports.
• Line clearance for batch to batch and product to product changeover.
• Ensure that good aseptic practices are followed inside the facility.
• Review of facility, process and EHSS risk assessment.
• Ensure readiness for internal and external audits by periodic GMP rounds.
• Issuance of logbooks and annexures for execution, review of executed logbooks and annexures.
• Review of qualification and validation documents for compliance against GMP standards and current industrial practices as per guidelines.
• Support in equipment and utility qualification activities.
• 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 of Science / Master of Technology -Biotechnology/Bioprocess Engineering

Technical/functional Skills:

• Should be familiar with the In-process Quality Assurance activities pertaining to Biologics.
• Tactful Communication.

Experience: 6 to 10 years experience in Biopharma manufacturing/ testing/ compliance/ Quality Assurance.

Behavioral Skills:

• Good Eye for detail.
• Good in creating and maintaining relations with cross functional teams for facilitation of work.
• Agressive but assertive on task completion.
• High influencing skills to complete the task at hand.
• Solution provider: Ability to provide solutions for complex problems.

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.