Manager/Sr, Manager Microbiology QA

Job Description for position
Manager/Sr. Manager Microbiology QA
Job Location:
Nivagen Pharma (INDIA) Pvt Limited., Ahmedabad.
Reporting to US site Quality.

About the Job:
Title of the Position: Manager/Sr, Manager Microbiology QA.
Responsibilities:
 Review and approval of SOPs, protocol, report and related documentations of Microbiology section.
 Ensuring compliance of microbiology related activities and documentation as per site procedures, policy and relevant regulatory requirement.
 Method Validation, and Testing: MLT, Sterility, BET (kCA/KTA), Particulate Matter Testing, Antimicrobial Effectiveness Test, disinfectant efficacy test, identification system, and Environmental and water monitoring
 Strong exposure in all kinds of microbiology method development/method validation for regulatory filing and submission
 Preparation and review of Media fill procedure, media fill protocol, summary and media fill matrix
 Ensuring Microbiology laboratory operation at Zero tolerance of Data integrity.
 Strong knowledge on remediating microbiology and keeping all time inspection readiness.
 Demonstrated strong technical knowledge in the areas of sterility assurance of aseptic cleanroom facilities, their processes, and equipment, including cleanroom design, media fill programs, aseptic training, cleaning and sanitization programs, microbiological monitoring, and design of EM programs. Review of QRM pertaining to sterility assurance at shop floor microbiology.
 Strong exposure on viable and non-viable monitoring at sterile manufacturing facility, Risk based location selection and remediation of viable and non-viable monitoring.
 To implement the contamination control strategy across all sterile facilities.
 Responsible for review and approve of all Manufacturing and Laboratory related investigations and Market complaints.
 Provide advice/guidance/CAPA and training for personnel to enhance aseptic practices & aseptic techniques in sterile process.
 Managing the operations of manufacturing assurance with special emphasis to clean room practice and sterility assurance aspects.
 Identify and oversee critical control points in the manufacturing process to prevent quality deviations
 Implement and monitor corrective and preventive actions (CAPA) to resolve issues and prevent recurrence.
 Assist during internal and external audits by providing necessary documentation and explaining in-process controls and testing procedures.
 Work closely with production, quality control, and engineering teams to resolve quality issues and implement process improvements.
 Participate in risk assessments to identify potential quality issues and implement mitigation strategies.
 Conducting audit and ensuring compliance.

Qualifications:
Education/Experience:

 A master’s degree in microbiology/Biochemistry/Biotechnology or Related Sciences from an accredited institution is preferred.
 Additionally, a minimum of 8 to 10 years of experience Microbiology testing or Microbiology Compliance or a related role within a pharmaceutical or GMP-regulated environment, or equivalent experience in related fields, is necessary

Knowledge, Skills, and Abilities:
 Practical experience on microbiology testing i.e. sterility, microbial limit test, Endotoxin test, Environment and personnel monitoring etc. related method validations and documentation.
 Strong analytical and problem-solving skills with experience in root cause analysis and CAPA implementation.
 High level of attention to detail, particularly in identifying quality deviations and documenting production processes.
 Proficiency in using quality testing equipment and familiarity with statistical process control (SPC) methods
 Strong understanding of GMP, FDA regulations, and other relevant pharmaceutical industry standards.
 Excellent communication skills, both verbal and written, for effective collaboration and documentation
 Excellent communication and organizational skills.
 Ability to work effectively as part of a cross-functional team, including production, quality control, and regulatory affairs.
Job Requirements:
Preferably having valid US (B1/B2) business visa.