Syngene Quality Control Jobs

Syngene Quality Control Jobs – MSc Microbiology Apply

Syngene Quality Control Jobs – MSc Microbiology Apply. Syngene MSc Microbiology Job. Check the details on the positions available, the job description, the key responsibilities, work experience, functional experience all below:

Designation: Junior Manager

Job ID: 7585

Job Location: Bangalore

Department: Quality Control-Microbiology

Job Description:

Key Responsibilities:

  • Review/approval of all microbiology related documents, records and data, which are in agreement with the Quality system.
  • Review of Finished Product, In-process and raw material specifications, Method of
  • Analysis protocol for different validations.
  • Review of protocol for cleanroom/area qualification/requalification of the cleanroom/area and water generation and distribution systems.
  • Reading of plates for the analysis performed by other analysts and reporting of results.
  • Responsible to ensure the analysis as per the written procedure and recording the observations contemporaneously in the respective records.
  • Attend the queries related to Microbiology during audits.
  • Ensure staff is trained appropriately to perform environmental monitoring, sampling and microbiology analysis of utility samples, stability samples, raw materials, intermediates and products.
  • Responsible for work allocation and execution as per the requirement.
  • To comply with the requirements to all relevant QA/QC and other relevant SOP’s.
  • Responsible for investigation and closure of QMS related activities like Laboratory incidents, OOS/OOT and deviations.
  • Responsible for coordinating with QA for all investigations.
  • Ensure the cleanliness of the workplace and maintain the laboratory neat and tidy.
  • Responsible for training of new joiners.
  • Responsible for attending calls from clients and interactions with them.
  • Review of SOP/SOP-E/GP and training for the same.
  • To ensure that all staff in the group maintains a personal training record.
  • Maintenance and calibration of measuring/testing equipment belonging to the Quality Control Microbiology Laboratory in coordination with the Maintenance Department.
  • Responsible to comply with the current procedures on good documentation practices.
  • To interact with contract testing laboratories for the execution of sample outsourcing activity as per relevant SOPs.
  • To review the results reported by approved contract-testing laboratory against In-house protocols /Specification.
  • Investigate any failures/deviation reported by contract testing laboratory.
  • Responsible to ensure all elements of the analysis follow-on and are dated and time-stamped in an expected sequence/activity-chronologically traceable.
  • Interaction with the cross-functional team for the smooth functioning and other requirements of a microbiology lab.
  • Responsible for issues/requirements/troubleshooting for the analyst to be resolved immediately.
  • Provides technical subject matter expertise based on familiarity with current regulatory guidelines on facilities monitoring and microbiological testing, draft responses to client/regulatory questions.
  • Responsible to develop and execute continuous improvement initiatives within QC Microbiology.
  • Maintaining the training records as per the requirement of the Quality System.
  • Effective coordination towards audit observation and CAPA.
  • 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: M.Sc. Microbiology

Technical/Functional Skills:

Should be conversant with the testing skills such as

  • Microbial Enumeration Test
  • Test for Specified Microorganisms
  • Bacterial Endotoxin test
  • Sterility Test
  • Test for Water activity
  • Antimicrobial effectiveness testing
  • Antibiotic and Vitamin assay

Experience: 06 – 09 years

Behavioural 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.

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