Your browser does not support javascript! Please enable it, otherwise web will not work for you.

Microbiology - Deputy Manager / Manager @ Biological E

Home > Production & Manufacturing

 Microbiology - Deputy Manager / Manager

Job Description

  • Preparation of SOPs ,Protocols i.e One time studies, method validations required for the microbiology laboratory.
  • Assessment of Equipment design versus URS/Design qualification.
  • Hands on experience on green field projects i.e new laboratory Set-up , AHU, Facility and equipment qualifications.
  • Microbiology equipment qualifications and to ensure instruments / equipments CSV, calibration, performance verification, preventive maintenance checks (PMP) as per the schedule.
  • Responsible for review, closure of reports and submission to cross functional departments.
  • To ensure the availability of necessary resources (consumables) for smooth and timely execution of the analysis.
  • To initiate and participate in QMS activities like OOL, Change control, CAPA and Deviations.
  • To co-ordinate with cross-functional teams for closure of QMS activities.
  • To ensure the Good Laboratory Practices (GLP) and Housekeeping activities inside the Laboratory.
  • To perform Laboratory Rounds to ensure online compliance.
  • Review and Risk assessment preparations of Environmental & Process Monitoring in Grade A, B, C and D areas in Passive Active and Surface Monitoring location selection/ Frequency.
  • Execution of the Media fill simulations & Area / Clean room qualifications.
  • Review of utility sampling Water analysis and Trend preparation of EMP, Water and Environmental Isolate in clean room.
  • Expertise in the testing/validation activities i.e MLT, Sterility, BET, Container closure integrity test, Microbial Limit testing, Water testing, Biological indicator enumeration of paper strips, SS disc, capsules and ampoules.
  • Regulatory Audit exposure is mandatory and good presentation, compliance report writing skills

Job Classification

Industry: Pharmaceutical & Life Sciences
Functional Area / Department: Quality Assurance
Role Category: Production & Manufacturing
Role: QC Microbiologist
Employement Type: Full time

Contact Details:

Company: Biological E
Location(s): Shamirpet

+ View Contactajax loader


Keyskills:   Injectables

 Fraud Alert to job seekers!

₹ Not Disclosed

Similar positions

Quality Engineer-Performance & Resilience Management

  • IBM
  • 3 - 5 years
  • Hyderabad
  • 8 hours ago
₹ Not Disclosed

Engineer - Quality ( Tata Firewall For Tier1 Auto Mnc @ Sanand) 4-6lpa

  • Call Prem
  • 3 - 8 years
  • Sanand
  • 12 hours ago
₹ 4-4.5 Lacs P.A.

Opening For Cloud Qa Engineer - Usa Based Start Up-bangalore

  • Human Capital
  • 7 - 11 years
  • Bengaluru
  • 3 days ago
₹ 22.5-32.5 Lacs P.A.

Senior Executive - QC

  • Piramal Finance
  • 2 - 6 years
  • Medak
  • 4 days ago
₹ Not Disclosed

Biological E

Visit our Web site at www.biologicale.com