Pakistan Job Openings
Pharmatec Pakistan (Pvt.) Limited
Officer / Senior Officer Microbiologist
Karāchi
FULL TIME
November 17, 2024
- Conduct microbiological testing on raw materials, in-process samples, finished products, and environmental samples to ensure compliance with quality standards and regulatory requirements.
- Perform a range of microbiological assays such as microbial identification, sterility testing, endotoxin testing (LAL test), bioburden testing, and microbiological characterization.
- Ensure all testing is conducted according to standard operating procedures (SOPs), quality protocols, and good laboratory practices (GLP).
- Oversee the environmental monitoring program for production areas, clean rooms, and controlled environments to ensure microbial contamination is within acceptable limits.
- Perform routine air, surface, and water sampling, and interpret results to ensure environmental conditions meet established criteria.
- Analyze trends in environmental monitoring data and collaborate with other departments to implement corrective and preventive actions when needed.
- Ensure that microbiological testing procedures and results comply with industry regulations (e.g., c GMP, ISO, FDA, USP) and company standards.
- Maintain accurate and comprehensive records of microbiological test results, investigations, and deviations in compliance with regulatory and internal documentation requirements.
- Assist in the preparation for internal and external audits, ensuring that all microbiological documentation is complete and audit-ready.
- Lead investigations related to microbiological deviations, non-conformances, and product quality issues, including root cause analysis and the implementation of corrective actions.
- Collaborate with production, quality assurance, and R&D teams to identify, investigate, and resolve microbiological issues affecting product quality.
- Review and analyze microbiological data to identify trends, potential risks, and opportunities for process improvement.
- Provide guidance and mentorship to junior microbiologists, laboratory technicians, and other staff members, helping them develop their skills and knowledge in microbiological testing and laboratory procedures.
- Lead and coordinate daily laboratory operations, ensuring optimal resource utilization, timely testing, and compliance with safety and quality standards.
- Develop training materials and conduct training sessions for team members on microbiological techniques, laboratory safety, and regulatory compliance.
- Participate in the development and validation of new microbiological methods and technologies to improve laboratory testing efficiency and accuracy.
- Contribute to continuous improvement initiatives by identifying areas for process optimization, efficiency gains, and risk mitigation within the microbiology lab and testing procedures.
- Stay current on microbiological research, industry trends, and regulatory changes to ensure the laboratory remains compliant with the latest standards.
- Manage microbiological projects, ensuring timely completion and alignment with quality goals.
- Collaborate with cross-functional teams, including quality assurance, production, and regulatory affairs, to resolve microbiological issues and ensure product quality across the organization.
- Lead or participate in investigations, root cause analysis, and the implementation of corrective and preventive actions (CAPA).
- A Bachelor's or Master's degree in Microbiology, Biological Sciences, Biotechnology, or a related field is required.
- A minimum of 3-5 years of experience in microbiological testing within a regulated environment (e.g., pharmaceutical, biotechnology, food safety, or cosmetics).
- Experience in environmental monitoring, sterility testing, bio burden testing, endotoxin testing, and microbial identification techniques.
- Previous experience in mentoring or supervising a team is highly desirable.
Pay: Rs50,000.00 - Rs65,000.00 per month
Expected Start Date: 25/11/2024
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