Senior Executive - Quality Control - Biologics Job in Syngene International

JOB DESCRIPTION

Designation: Senior Executive

Job Location: Bangalore

Department: Quality Control-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 planning and execution of Bioassay and binding ELISA analysis for Biologics of drug substances/ finished product.

Job Description

Key Responsibilities:

• Responsible for preparation of documents such as SOPs, IOPs, EOPs etc.
• Preparation of batch release documents like specifications, STPs with observation data sheet, verification protocols, method transfer protocols etc.
• Responsible to perform the method transfer analysis and verification activity with documentation for the samples of in-process/finished product.
• Responsible for uploading and assigning SOP / EOP / IOP in LMS.
• Responsible to involve and participate during the preparation and general laboratory readiness for the internal / external / client audits.
• Responsible to complete all planned quality & compliance training as and when required by the department / section or asked by the HOD / Section Head.
• To prepare the complete list of materials (CLM) required for various project.
• Responsible to initiate and inform immediately to department HOD/designee, if there are any laboratory incidents, deviations, change controls and out of specification results were observed.
• Responsible to conduct any job assigned by the superior.
• Responsible for the training coordinator activity which includes providing of training questionnaire, submitting the GTR to archival QA, preparation of JD, training matrix, training binder, review of training files and assigning training in LMS.
• Perform sample management duties which may include movement and storage of samples, reconciliation of sample receipt and aliquoting of samples.
• Responsible for the preparation of stability study related documents like, stability study protocols, observation data sheet, analysis report, stability summary and trend sheets. Responsible for the execution of stability samples charging for stability study. Assistance in setup of bioassay lab as per the direction of Supervisor/ Section Head.
• Preparation of batch release documents like specifications, STPs with observation data sheet, verification protocols, method transfer protocols etc.
• 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 (Biochemistry/ biotechnology).

Experience: 3 -6 years

Technical/functional Skills:

• Knowledge on Bioassay and Binding ELISA analysis for Biologics substances/ finished product.
• Experience on method transfer analysis and verification activity with documentation for the samples of in-process/ finished product.
• Ample knowledge on LIMS.

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.