Supervisor
PHARMA INTERNATIONAL
Total years of experience :14 years, 7 Months
• Supervise staff to carry out that the manufacturing and packaging processes is according to BRs and GMP regulations.
• Finishing BMRs and BPRs for sterile and non-sterile products.
• Internal and External audit.
• Follow up for manufacturing and packaging deviations and change controls.
• Follow up for shipping processes with related departments.
• SOPs management and updating in departments.
• Continuous training and evaluation for staff and new employees.
• Troubleshooting for daily activities for production and packaging departments for sterile and non- sterile products.
• Working on SAP system.
• Follow up OOS, supplier notifications, CAPA and complaint.
• Supervise staff to carry out laboratory analysis according to established methods and meeting quality control (QC) standards.
• Perform a variety of tests for microbiological assays including microbial limit test, diagnostic test for designated organisms according to client’s requirements and methods, SOPs, current compendial USP, EP, BP, and ICH guidelines for microbiological testing.
• Perform a variety of tests including microbial limit test, water testing, preservative challenge test, endotoxin test, sanitizer efficacy test, BI test, UV challenge test, biological assays for antibiotics, sterility test and different kind of validation tests for pharmaceutical products.
• Perform environmental monitoring and identify recovered organisms and media preparation, growth promotion test for every culture media.
• Perform temperature monitoring of incubators, refrigerators, and micro lab.
• Perform autoclave operation and maintenance.
• Ensure compliance with GMP, QCL`s policies/procedures, and demands.
• Schedule work flow through the department so that client deadlines are met in a timely fashion; monitor throughput and performance
• Monitor and maintain lab OC standards, responsible for the quality of all data released by the department.
• Review analytical data, manage / train microbiological analysts.
• Solve day to day production and process problems within the department.
• Work in partnership with other supervisors to solve client problems to ensure quality and customer satisfaction standards are met.
• Review and evaluate technical data, generate reports, and documents is needed.
• Train &motivate staff, set goals, review performance and assess training needs.
• Plan and initiate procedures and systems necessary to ensure the maintenance and improvement of the company quality program.
• Develop new laboratory methods in response to client/market needs.
• Accountable for maintaining production and quality targets and ensuring optimal staff levels to achieve production, quality and financial targets.
• Responsible for designing co-coordinating and executing training programs that are consistent with management objectives, includes quality system awareness, continuous technical improvement and personnel performance reviews .
• Participate and document laboratory document accidents and OOT, OOS or deviation investigation.
• Ensure each person within their responsibility has undergone in orientation and has sufficient knowledge for their safety and health while at work.
• Ensure that each person has sufficient information, resources and materials to do their job safely.
• Directly responsible for their area housekeeping and cleanliness on a daily basis.
• Accountable for routine and non-routine equipment maintenance.
• Directly responsible for ensuring all safety equipment is in place on a daily basis.
• Ability to prepare SOPs, protocols, and develop methods as assigned.
• Understanding of USP, EP, BP, GMP, cGMP and ICH guidelines for microbiological analysis.
• Ability to interpret and analyze data.
• Capable of interacting with all levels of management, suppliers and clients.
• Work well under pressure.
QC microbiology Analyst for sterile products