Microbiology Manager

Microbiology Manager

Monroe, NC

Full-Time, Permanent

Overview

The Microbiology Manager reports to the Associate Director / Director, Microbiology. The primary responsibilities are to manage and coordinate staff performing microbiological testing, support the manufacturing of aseptically process and terminally sterilized pharmaceutical products. Provides technical leadership, daily oversight and subject matter expertise as needed to manage the QC microbiology laboratory functions:

Reading, review and trend analysis of environmental monitoring and water test data

Contamination Control Strategy, Media Fills, Qualification for sterilizers

Developing and validating microbial test methods for bioburden, sterility, liquid particle counts and endotoxin test

Microbiological testing of raw-materials, in-process materials and finished products

In this role you will be the primary contact for the microbiology laboratory, collaborating with personnel outside of the department, facilitating timely and right the first time data management and reporting and assuring testing is completed in support of manufacturing timelines and regulatory standards.

Responsibilities

Operational Excellence (40%)

Ensuring compliance to system and procedures in the department and documentation.

Preparation of the Microbiology Laboratory for internal and external audits.

Ensure online documentation in microbiology laboratory.

Ensure compliance, revision and updates to SOPs as per Good Microbiology Laboratory practices and pharmacopeia.

Updating specification and standard test procedures of the microbiology section.

Work distribution to subordinates of Microbiology Section.

Procure consumables and other materials.

Ensure annual maintenance contact renewal (if any), calibration of laboratory instruments.

Prepare risk assessment in for various processes in microbiology laboratory.

Providing support for procurement and qualification of new equipment required in microbiology laboratory.

Ensure timely sampling, analysis and release of environmental, water samples.

Ensure timely analysis and release of Raw material, finish products and packing materials.

Ensure 100% training of subordinates in microbiology department as per the job requirement.

Review of change control, incidents, protocols and deviation of other departments related to microbiology.

Ensure requalification and calibration of instruments in micro lab as per the schedule.

Response preparation for internal and external audit observation. Implementation of CAPA in micro lab.

Review of regulatory audit observations at other sites and ensure compliance in microbiology department of the site.

To interact with site QA and inform about failures/ OOS / OOT / incident / Non compliances.

Stakeholder (40%)

Responsible for management of Microbiology department

Responsible for coordination with Production / R&D/QA/QC for various activities related to microbiology

Interact with different departments in case of OOT and OOS observations related to microbiology

Train and implement cGMP practices related to microbiology at all the manufacturing and related departments

Innovation (15%)

Training of manufacturing staff w.r.t. aseptic practices and microbiological staff

Financial (5%)

Providing support in Revenue and Capex Budget as per spent analysis project. Ensure financial prudence in resource planning, allocation and manage within approved budgets while building best in class quality processes and systems at site.

Maintain quality system controls to ensure no critical and major market complaints.

Ensure that all statutory and regulatory compliance are regularly monitored and is in a state of compliance as applicable.

Take appropriate steps to reduce wastages and losses in the analysis process and build improved efficiency

Education and Experience

Bachelor degree in Pharmaceutical Sciences, Microbiology or equivalent required. Master’s degree in microbiology or equivalent, preferred

At least 5 years in the field of Pharmaceutical (formulation facility).

Background of functions of Microbiology.

Experience of working with Injectable facility.

Experience working with Audits

Knowledge of cGMP, validations and qualifications, regulatory guidelines, US Pharmacopoeias, Internal auditing, handling of regulatory inspections, well acquainted with QMS, well versed with change control/deviations and market complaint management system