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Pharmalucence
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Pharmalucence is an Equal Opportunity Employer
Sr. Manager, QC Microbiology


Summary

Responsible for all aspects of QC Microbiology of pharmaceutical manufacturing site. Ensure that all pharmaceutical products meet specific quality standards through the effective evaluation, validation and documentation of activities related to the microbiological aspects of the manufacture and testing of products.


Responsibilities and Tasks

  • Responsible for the process/ environment / training / qualification / sampling / incidence & investigation in microbiology - sterility assurance point of view.  
  • Plan and coordinate QC microbiology priorities by working in collaboration with Microbiology team. 
  • Train employees on aseptic technique, environmental monitoring of the clean rooms and QC Micro test procedures
  • Responsible for inspection of aseptic proficiency testing
  • Perform routine clean room audits, report findings to management and makes supports generation of  recommendations for process improvement
  • Perform root cause/analysis and CAPA plan for unplanned deviations in Microbiology area
  • Support MFG operations in investigation and CAPA planning for microbiology related unplanned deviations
  • Perform routine inspection of in-process and final products 
  • Review current test methods and required updates for compliance to pharmacopoeia
  • Perform QC inspection and process checks/verification
  • Represent quality function in manufacturing classified suites during processing
  • Direct staff ensuring  that all activities are documented, executed and in compliance with current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLP), ISO Quality Assurance, company policies, standards and procedures

Knowledge Skills and Abilities

  • Risk assessment / impact assessment of aseptic process. 
  • Experience with risk assessment of environmental monitoring sampling sites identification. 
  • Works under minimal supervision using Standard Operating Procedures and good judgment to effectively coordinate and execute assigned activities in support of production, Quality Control and Research & Development activities
  • Strong verbal, written and interpersonal communication with an emphasis on creating a motivated, effective working team
  • Strong organizational skills, the ability to prioritize work and manage multiple tasks independently
  • Demonstrated experience conducting investigations, writing protocols, SOP’s, validating methods, staff training,
  • Strong computer skills and proficient at word processing and utilizing spreadsheets
  • Experience in a clean room environment required
  • Knowledge of cGMP and GLP, FDA/USP and applicable global regulatory requirements 
  • Strong industry experience in pharmacopoeia testing, sterilization validation and general pharmaceutical microbiology
  • Knowledge of microbiology (industrial), environmental monitoring and aseptic techniques 
  • Experience with sterility testing, Endotoxin assays and validation, microbiological limits testing, knowledge of USP and EP/BP method/validation regulations, Microbiological identification methods

Education and Experience

  • BS in Microbiology required
  • Minimum 8-10 years related experience with minimum 1-2 years related experience in a supervisory role

 

 

 

Disclaimer
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
 
Notice to Agency and Search Firm Representatives:
Sun Pharmaceuticals Industries, Inc. (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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