Senior Executive - Quality Assurance - Biologics Job in Syngene International Limited

JOB DESCRIPTION

Designation: Senior Executive

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 Analytical Quality Assurance activities pertaining to Quality Control Biologics (AQA activities of QC Biologics).

Job Description:

Key responsibilities:

• Review, approval of RM/PM/Consumable reports and release in SAP.
• Coordination in preparation and review of the QA SOPs in-line with current pharmaceutical guidelines.
• Responding to queries providing support to customer/regulatory on analytical related documents/requests as per the customer/regulatory requirement.
• Issuance of Analytical documents and document related Raw Materials/Packing Materials/Consumables.
• Review of analytical test records, Analytical testing records, Analytical Method validation, Analytical method transfer, protocol and report as per written procedures
• Review of stability summary and stability reports generated by QC as per written procedures.
• Handling and being part of the investigations related to deviations, Laboratory incidents, Out of calibrations, Out of specifications, CAPA and Out of trend.
• Handling & management of deviations, Laboratory incidents coordinating in identifying the root cause investigations with CAPA identification.
• Handling, review, evaluation of change control, verification and implementation of the Corrective and preventive action.
• Review of specifications and STPs for RM/PM/IP/FP of QC Biologics.
• Review of all laboratory analytical standard protocol, Reports & COAs.
• Review of Instrument operating procedures, IQ/OQ/PQ/DQ of all instruments of QC.
• To ensure implementation of all EHSS norms to create safe working environment.
• Training of employees on various aspects like good documentation practices and Good Laboratory 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: Masters in Science

Technical/functional Skills:

• Should be good in Quality Control instrumentation.
• Should have knowledge in Analytical testing records, Analytical Method validation, Analytical method transfer

Experience: 3-6 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 be a focuses 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.