Pfizer
Location
Visakhapatnam | India
Job description
Develop innovative, advanced new concepts that improve processes or products across own and related disciplines.
Partner with the Quality Operations (QO), Manufacturing Operations and Site Leadership Teams to ensure the site goals and objectives are met and supported by a highly flexible and agile team.
Lead the microbiology business, develop and monitor the capital and expense budgets for the function ensuring all teams operate within the formalized budgets.
Provide leadership and direction to the assigned teams responsible for management and administration of procedures, documentation, records management, computer system validation, audits, inspections and compliance effectiveness.
Approve microbiology quality assurance reports and investigations for deviations from approved processes or specifications.
Effectively collaborate with functional leadership to ensure local and global processes are well defined and presented in procedures.
Assess existing situations and suggest continuous improvements to increase compliance and innovation.
Guide the process for recruitment of new staff, staff development, either directly as a team leader, or indirectly as a senior member of the team .
Provide functional leaders with performance feedback for site-based colleagues.
Provide ongoing education on Quality to relevant functional groups, to increase awareness and understanding of requirements and enhance the Quality Culture.
Lead and support initiatives that contribute to building and strengthening the quality culture within the microbiology unit.
Build and oversee a high performing team of professionals and managers to deliver on targets and strategic projects.
Create a motivated, committed and engaged project team that fosters innovation and professional development.
Expertise in Testing - MLT, BET, Sterility, and samples for Environmental Monitoring.
Experience in overall management and operations of Microbiology Lab, with special emphasis to clean room / sterility testing area.
Capable of handling failure investigations for sterility, positive media fill, unusual trends in EM and water samples, with Analytical thinking, arriving at RCA and suggesting CAPA.
Knowledge of qualification and operation of commonly used equipment in microbiology lab - autoclave, incubators, LAF, etc.
To ensure the laboratory functions are in line with the current cGMP requirements. To ensure the compliance to quality/safety/cGMP procedures.
To support the Regulatory, Corporate and customer audits. To provide timely compliance to the audit findings.
Ensure the Good Laboratory Practices(GLP) and House keeping in the laboratory.
To provide the necessary resources for smooth and timely execution of the analysis.
To identify the manpower needs and to recruit the people with adequate competencies. To induct the new joiners as per the procedures.
To ensure adherence to Good Documentation Practices and monitor the documentation errors and to create awareness among the teams through trainings and periodic interactions for minimization of the same.
To review the method validation/verification protocols and all other miscellaneous studies to back up the routine microbial monitoring procedures and approve.
To coordinate with the cross functional teams(CFTs) for any unresolved issues and to resolve.
To escalate any unresolved quality/resource related issues to the next level.
To participate along with the CFTs in any manufacturing/ EM related investigations and provide oversight on microbiology aspects to the investigation teams.
Creating the quality/compliance/safety awareness among the team members and drive the RFT and Compliance culture
To keep up to date with the changes in the pharmacopeia / guidelines / regulations and cascade the same to the teams for awareness and to organize the creation/revision of the laboratory procedures in line with the changes for compliance.
Qualifications
Must-Have
Master's Degree mi Microbiology and 18+ years of experience .
Pharmaceutical experience in Injectable only
People management and talent development experience.
Leadership role for 3 to 5 years at complex / sterile injectable site
Facilitated as Host / Escort different regulatory audits such as US FDA / MHRA / Health Canada / TGA
In-depth knowledge and experience of pharmaceutical cGMP , principles and concepts of relevant quality processes based on previous roles.
E xcellent interpersonal, communication, negotiation, influencing and problem-solving capabilities.
Ability to function autonomously in a matrix model and in a team environment.
Good computer skills, including Microsoft Office, with proficiency in Word and Excel
Proven business management capability.
Able to communicate complex information and analyses to a variety of scientific and nonscientific audiences in both verbal and written formats.
Job tags
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