Junior Manager Quality Control-Biologics

Job Description

Designation: Junior ManagerJob Location: BangaloreDepartment: Quality Control-BiologicsAbout SyngeneIncorporated 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 DescriptionKey Responsibilities:

• Daily laboratory monitoring, responsible to perform, record and review the daily / monthly verification, calibration of equipment and instruments.
• Responsible to involve in the QMS investigation and providing the recommendation during the investigation in consultation with section head/group leader.
• Review of documents pertaining to Method validations, batch release, instrument/equipment qualification, Calibration and Computer System Validation.
• Closure of laboratory incidents related to Analytical team.
• Review of specification/method of analysis/ODS in LIMS and EDMS.
• Preparation and review of batch release documents like specifications, STPs with observation data sheet, verification protocols, method transfer protocols etc
• Perform sample management duties which may include movement and storage of samples, reconciliation of sample receipt and aliquoting of samples.
• Responsible to troubleshoot the problems, provide technical guidance, and mentor junior staff.
• Responsible for the preparation and review of Stability study related documents like, stability study protocols, observation data sheet, analysis report, stability summary and trend sheets.
• 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.
• Review of all the compliance documents on monthly basis for the Equipment and instruments documents like calibration records/reports, logbooks related to Analytical and Biochemical sections.
• Participating in internal/external audits and inventory management in LIMS (Reference standard, Column and Chemicals)

• 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 scienceExperience: 6 10 yearsTechnical Skills:

• Technically sound in analytical methods like (HPLC, UPLC, UV spectrophotometer, pH meter, Weighing balance, PCR, CGE and iCE).
• Preparation of documentation such as SOPs, IOPs, EOPs etc.
• Preparation of batch release documents like specifications, STPs with observation data sheet, verification protocols, method transfer protocols, validation protocols and reports etc.
• Responsible to perform the method transfer analysis and verification activity with documentation for the samples of in-process/finished product.

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.,

Keyskills :
consumer goodsinspectionanimal healthequal employment opportunityph metercalibrationcontinuous improvement facilitationmethod transfercommitment towards workbatch releaseisoquality control