Title: Assistant Manager, Microbiology
Company Name: DBL Pharmaceuticals Ltd. (a concern of DBL Group)
Vacancy: Not specific
Job Location: Gazipur
Employment Status: Full-time
Educational Requirements:
∎ M.Sc in Microbiology from any renowned University .
Experience Requirements:
∎ 6 to 9 year(s)
∎ The applicants should have experience in the following area(s):
Micro-Biologist
∎ The applicants should have experience in the following business area(s):
Pharmaceuticals
Job Responsibilities:
∎ Establish, Supervise and Ensure Good laboratory practices (GLP) for microbiology laboratory.
∎ Plan, Organize and control resources and microbiological activities.
∎ Write, review and update operating procedures and ensure that the microbiological testing methods and specifications are in line with current pharmacopoeia, regulatory guidelines and Environment and Safety regulations.
∎ Establish protocols and execution/participate in critical systems, sterilization equipment and laboratory equipment validation/re validation activities.
∎ Prepare in-depth risk assessment for all new product development and provide Microbiology expert summary for Regulatory submission.
∎ Ensure/perform various microbiological tests and should have in-depth knowledge on -
∎ Media preparation, Storage and Use, Growth Promotion Test, Reference culture maintenance, Water test, Microbial Contamination Test (Bulk/Finished Products/ Raw and Packaging materials), Bacterial Endotoxins Test (Gel-Clot & Kinetic method), Microbiological Assay of Antibiotics, Identification of Microorganisms, Environment Monitoring (Air Borne Particle Count, Settle plate Count, Contact Plate, Rinse and Surface Swab, Air sampling and Personnel monitoring hygiene), Efficacy test of preservatives, Efficacy test of Disinfectants, Sterility Test (All Sterile Raw Materials, Packaging Materials and Finished products), Clean room qualification, Cleaning validation, Qualification and maintenance of Laboratory instruments, Gowning/ Personnel qualification, Media simulation test, Data entry, Trend analysis, Evaluation and Investigation, ensure implementation of actions.
∎ Ensure issues, maintains records/log books, report generation and release of microbiological tests results.
∎ Knowledge on good documentation practices, its implementation, data integrity and GMP compliance.
∎ Investigation on microbiological result failure, root cause analysis, risk assessment, appropriate decision making, action taking and ensure follow up of implemented actions.
∎ Conduct training for the development of microbiology laboratory personnel/other for skill development.
∎ Provide technical support to R&D for new product development for microbiological aspect.
∎ Ensure adequate microbiological inventories/spare/consumables of the equipment/testing.
∎ Knowledge on functional operation of laboratory equipment/instruments.
Additional Requirements:
∎ Computer literacy in MS Office & Excel,
∎ Work experience both in sterile and non-sterile facilities.
∎ Ability to take challenges to establish the quality system.
∎ Experience on SAP/ERP system and other spreadsheet software data analysis.
∎ Strong personal & professional ethical values are essential.
∎ Candidates must possess excellent communication & interpersonal skills and Leadership Quality to lead the team successfully and achieve organisational goal.
Compensation & Other Benefits:
∎ We offer excellent work environment, attractive compensation package and performance-based career progression.
Application Deadline: October 19, 2019
Company Information:
∎ DBL Pharmaceuticals Ltd. (a concern of DBL Group)
∎ Address : Capita South Avenue Tower, 6th Floor
House No # 50, Road No # 03, Gulshan Avenue
Gulshan 1, Dhaka - 1212, Bangladesh
∎ Web : dblgroup.taleo.net/careersection/ex/jobsearch.ftl
Category: Medical/Pharma
Source: bdjobs.com