Microbiology – Manager.

  • 16 Oct 2019
  • Mumbai
  • As per Industry Standards
  • 5 to 7 yrs

Job Criteria:

SECTOR: Healthcare
INDUSTRY: Pharmaceuticals, Biopharmaceuticals, Bulk Drugs
FUNCTION: Bio Tech/R&D/Scientist
KEY SKILLS: ISO, GMP, Approved by FDA for Micro + Sterility
ROLE: Microbiology – Manager.

Job Summary:

  • Our client, a growing global health care company that manufactures pharmaceuticals and medical devices, is looking to hire a “Microbiology Manager” with 5+ years’ related experience in a GMP environment.
  • Responsible for the acquisition of state of the art technologies and instrumentation, capable of implementing new technologies in the cGMP environment in support of ongoing production activities.
  • Think strategically for development and improvements to current monitoring and testing programs for ISO and cGMP production and test methods to meet the requirements for global compliance.
  • This is a great opportunity to join an extremely stable and growing organization with an international presence. This position is a key team member in meeting the company’s strategic plan for continued compliance.

Job Responsibilities:

  • To ensure the department is equipped with properly calibrated and serviced equipment designed for global compliance. Must be able to understand and scientifically interpret data utilizing and analytical skills.
  • Analyzing all microbiological test data to include drafting and preparation of reports, presentations, and formal communications as to the current state of control for the manufacturing and drives corrective actions as needed.
  • Accountable for establishing and executing corrective actions in response to excursions in controlled environmental areas to maintain full global compliance.
  • Responsible for compendium testing and other laboratory methodology in support of “troubleshooting” operational issues in both production and laboratory environments.
  • Accountable to ensure the development of all team members to ensure they are adequately trained, mentored and motivated, as well as adhere to quality performance standards.
  • Provide guidance and mentoring in the development of test protocol designs for efficient implementation of validation for test methods, equipment and instruments used in testing or monitoring of the ISO and cGMP environment in support of ongoing production activities.
  • Accountable for maintaining both the operational and capital budgets for the department. Plan and coordinate training leading to the development of cross-trained, self-directed work teams in line with total quality management concepts.
  • Keep quality control, supervisory and management personnel informed of all relevant events impacting the operations and performance of the department. Collaborates with other departments to increase synergy and efficiency.
  • Responsible for Environmental, Health and Safety compliance. Represent the department with active participation in ISO and cGMP inspections and audits.
  • Excellent interpersonal and communication (written & verbal) skills.

Job Specifications:

  • Certification: Approved by FDA for Micro + Sterility. (Must)
  • Experience: 5+ years of related experience in a GMP environment. (Must)
  • Salary: Not a limiting factor for Experienced and Result-Oriented candidates.
  • Location:
  1. The applicant for Pharmaceutical – Nalagarh, Himachal Pradesh, INDIA.
  2. The applicant for Medical Device – Palghar, Maharashtra, INDIA.

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