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Associate Director Microbiology

4 months ago

Monroe, United States Glenmark Pharmaceuticals USA Full time

The QC Associate Director(AD), Microbiology manages a team of microbiologists to oversee all microbiological quality aspects of pharmaceutical manufacturing (injectable and OSD), including, but not limited to: sterility, environmental monitoring of warehouse, dispensing area, manufacturing, packaging, quality control, utility monitoring and site contamination control strategy. Implementation of Entry/Exit and gowning procedure while entering the classified areas including gowning qualification. Disinfection Validation study for different Disinfectants. Isolation and identification of different Environmental isolates.AD-Microbiology will also lead media fill program, cleaning verification program, hold time studies and sterilizer validation program. Preparation and implementation of the Standard Operating Procedures and Standard Testing Procedures written for performing various microbiological testing and good laboratory practices within microbiology laboratory. Oversee Validation and verification of microbiological test methods. Work as SME for representing microbiological aspects and controls implemented at the injectable manufacturing site for any internal or external audits.

Financial

* Preparation of 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

Operational Excellence

* 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.* 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

* Responsible for overall 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, OOAC , OOAL and OOS observations related to microbiology* Train and implement cGMP practices related to microbiology at all the manufacturing and related departments

Innovation

* Training of manufacturing staff w.r.t. aseptic practices and microbiological staff. Implement automation within Microbiology lab to bring more efficiency and eliminate data Integrity risk.

Education

Minimum Bachelor's degree in Microbiology with adequate experience.

Experience

* 10 15 years in the field of Pharmaceutical (formulation facility).

Background of functions of Microbiology.* Experience of working with Injectable facility will be an added advantage.

Knowledge and Skills (Functional / Technical)

Knowledge of cGMP, Validations and Qualifications, regulatory guidelines, US Pharmacopoeias, Internal auditing, Handling of regulatory Inspections, well acquaintance with QMS, well versed with Change control/deviations and market complaint management system.

Leadership / Managerial Attributes

Capable to lead team, good communications skills, front runner, GMP trainer.

Other requirements (licenses, certifications, specialized training)

Will be an added advantage if the individual has dealt with multiple audits personally #J-18808-Ljbffr