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Manager QC Microbiology

12.00 to 15.00 Years   Kolkata   13 Aug, 2021
Sygene
Job LocationKolkata
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaDoctor
EmploymentTypeFull-time

Job Description

Designation: ManagerJob Location: BangaloreDepartment: QC-MicrobiologyAbout 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. Key Responsibilities:

  • In conjunction with the Head of Quality Control, shapes the strategic direction of QC Microbiology through ownership and implementation of the cGMP Laboratory principles and system level enhancement.
  • Aligns department resources for development, implementation and maintenance of an effective facilities EM program, accountable for QC Microbiology facilities monitoring and microbiological testing,
  • Participates in preparation of annual budget requirements.
  • Provides technical subject matter expertise based on familiarity with current regulatory guidelines on facilities monitoring and microbiological testing, draft responses to client/regulatory questions.
  • Accountable for policies on microbiological testing and operations of the laboratory.
  • Manage and coach the staff through training along with managing their overall performance and development
  • Provides inputs on hiring decisions and access to resources.
  • Ensures the laboratory is properly equipped, provide recommendations for instrument acquisition and delegate accountability for ensuring all laboratory systems are appropriately qualified and maintained.
  • Includes accountability for laboratory performance, establishing effective metrics for monitoring department performance and respond to negative performance trends.
  • Works in conjunctions with Manufacturing to resolve/improve environmental monitoring trends.
  • Oversees quality systems deployment within the department, develops and execute continuous improvement initiatives within QC Microbiology.
  • Coaches and mentors staff, oversees effective utilization of all quality management systems by laboratory personnel, develop and maintain compliance metrics and report to management.
  • Participates in the site team which prepares for, hosts and responds to Regulatory/Client inspections, reviews and approvals of the facility and products
  • Writing, reviewing the Microbiology Documents/Procedures.
  • Ensures accomplishment of organizational improvement initiatives technically / administratively related to microbiology lab.
Educational Qualification:
  • M.Sc. in Microbiology
Technical/functional Skills:
  • Should be conversant with the testing skills such as
  • Microbial Limit Test
  • Test for Specified Microorganisms
  • Bacterial Endotoxin test
  • Sterility Test
  • Antimicrobial effectiveness testing
  • Environment Monitoring of clean rooms
  • Identification of Microorganisms
Experience:
  • 12-15 years of relevant experience
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 :
quality systemstechnical subject mattermanagement systemsconsumer goodsanimal healthquality controlquality managementquality management systems

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