Posted Jan 02, 2017 1 views
Job Purpose:
The Microbiologist will be primary responsible for all microbiological testing of production materials; raw, in-process and finished goods; environmental monitoring under static and dynamic conditions and personnel monitoring under GMP conditions. Responsible for process and equipment validation. Able to coach and mentor Laboratory Technicians.
Duties & Responsibilities:
- Responsible for daily operation and testing requirements for the people, equipment, location and environmental monitoring program.
- Supports regulatory compliance of the environmental monitoring program for the Heating Ventilation & Air Conditioning (HVAC), Compressed Air and Water Systems as relevant.
- Perform environmental monitoring program data base tracking and trending, data entry and quarterly reporting.
- Responsible for coordinating testing with contract laboratories (scheduling, submitting samples, reviewing results, conducting investigations and resolution of any issues that arise)
- Perform environmental monitoring excursion communication, reporting, investigation, disposition and corrective action process. Requires multi-department communication and approval for coordination of work performed (i.e. Operations, QC, Sanitization, Facilities and QA).
- Perform test method validations in support of microbiology operations and interpret the results.
- Support equipment and product cleaning and disinfection validations to for product re-qualification and new product qualifications.
- Supports regulatory compliance of the products by performing scheduled product/process re-qualification, new product qualifications, challenge and bioburden testing when necessary.
- Ensure regulatory compliance of product and material biocompatibility by performing safety assessments and testing for the medical devices to support existing product and/or process changes and new products.
- Assist with supplier audits, contract test labs and suppliers where applicable.
- Works and communicates effectively and professionally with others inside and outside the company.
- Solid understanding of international and domestic medical device GMPs/ Quality System Requirements.
- Understanding of international and domestic medical device microbiological requirements.
- Knowledge of the following 21 CFR 820, ISO 13485, WHO/UNFPA ,USP /BP Pharmacopeia , International Organization for Standardization (ISO) 10993, 14644, 14971 and other risk guidance standards to create the processes and supporting documentation preferred.
- To establish company wide hygiene procedures, changing room procedures, disinfectant controls, garmenting procedures and monitoring thereof.
Requirements:
- Requires BS in microbiology, biology or related science
- 1-2 years experience in pharmaceutical or medical industry with microbiological testing such as bioburden, new product validation, equipment validation, microbial identification, gram staining, purified water testing as per USP (membrane filtration, endotoxin and TOC), efficacy and growth promotion assay
- Experience with GMP laboratory operations
- Experience in environmental monitoring
- Excellent verbal and written communication skills
- Proven ability to meet deadlines for testing and reporting
- Proficient in the use of Microsoft Office Suite including PowerPoint
Job Details
Haji Sheikh Noor ud Din & Sons Pvt Ltd
After manufacturing & supplying tents & shelters for four decades, HSNDS proudly claims to be one of the largest tent manufacturers in South East Asia, and one of the world's largest suppliers of Emergency Relief Products. We are now supplying leading NGOs and Relief / Aid Agencies not just Tents but also a wide variety of other humanitarian/relief items such as Plastic Sheets, Fleece Blankets, Woolen Blankets, Kitchen Sets, Hygiene Kits, Sleeping Mats, Quilts, Jerry Cans, DuraNet, Buckets & so on. Our ideally placed offices in Pakistan, Switzerland & Dubai with warehouses in China, Dubai, Kenya, India & Pakistan are managed by proven professionals. Our long term partnership with NRS International, Noor Relief Services and CLARKE makes us the ultimate choice in terms of ability and capacity to respond to crisis of any magnitude. We try hardest to offer the best value for money. All our products are made to strict compliance of globally approved standards. With our warehouses stock piled with all emergency items at all times, we are able to fulfill your Relief & Emergency needs with ease no matter where your needs are. Our current position as a supplier with some of the biggest and best relief bodies speaks volumes of our ability to perform effectively, dependably and economically, especially at times when it matters most. Our global offices are available at all times to cater for your needs or for any other information or respond to any concerns you may have.
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