Sterility Assurance Expert
- Maatrom Solution
- 5 to 10 Yrs
- Multi-City, India
- 3 years ago
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Job Description
The successfulapplicantwill have strong experience:
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Aseptic/sterile manufacturing operations in the pharmaceutical industry
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Excellent working knowledge of GMP and regulatory requirements (FDA, EMA, PIC/s)
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Proven hands-on experience in sterility assurance and contamination control
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Ability to apply microbiological control concepts and risk assessment in a practical way and to coach / teach team members in these areas
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Hands-on experience in complex investigations in both preventive and reactive contamination control
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Knowledge and experience in microbiological test technologies/methodology
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Technical knowledge of aseptic facility design, clean room engineering, including particle and microbial control mechanisms, qualification and maintenance of clean rooms
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Technical Knowledge of microbiological methods and techniques.
Ipsen is a rapidly growing global biopharmaceutical company focused on innovation and specialty care with sales growth of 21.1%. Ipsen aim to make a sustainable difference by significantly improving patients health and quality of life through differentiated and innovative medicines in oncology, neurosciences and rare diseases.
If successful, you will be supporting the QA s Sterility Assurance Manager in the development, implementation and continuous improvement of contamination control strategies for API and aseptic manufacturing in compliance with cGMP.
Provide oversight and facilitate ongoing improvement of the site Aseptic Operator Training Programme to improve the understanding of risks and aseptic practices.
Provide technical support to ensure optimisation of microbiological control of new facility design, process design, maintenance, training, sampling, testing, and cleaning and disinfection activities.
Support the development of new and modern microbiological methods in collaboration with MS&T, BPD and QC.
Main Duties & Responsibilities:
The Sterility Assurance Expert will be responsible for:
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Supporting the development, implementation and continuous improvement of the site contamination control strategy for primary and sterile drug product manufacturing operations in compliance with all cGMP requirements
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Supporting a lean and efficient sterility assurance governance at IBL Wrexham through the review and reporting of QC sterility assurance data in line with company lead times and drive continuous process improvements
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Provide support to any sterility assurance or microbiological adverse trends or complex microbiological contamination events by detailed and thorough root cause analysis as required.
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Provide ongoing support, coaching and training of employees to improve understanding of risks and aseptic practices.
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Support the development and improvement of the trending programme for all aspects of Microbiological testing, Utilities and Environmental monitoring.
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Actively trouble shoot and challenge ways of working to seek efficiencies and continuous improvements through the use and implementation of modern microbiological testing methods (including microbial identification and rapid sterility testing) in collaboration with the QA Sterile Manufacturing Manager and QC.
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Provide technical input based on knowledge and experience of Microbiological assays and sound understanding of non-sterile and sterile manufacturing:
Employement Category:
Employement Type: Full timeIndustry: Pharma / Biotech
Role Category: Pharmacist / Medical RepresentativeMedical Transcription
Functional Area: Not Applicable
Role/Responsibilies: Sterility Assurance Expert
Contact Details:
Company: M/s Chauhan CraneLocation(s): Multi-City, India
Keyskills: air filtration sterility assurance microbiological analysis pharmaceutical microbiology contamination control clean room design regulatory requirements regulatory intelligence microbiology techniques
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