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The Role:
Facility environmental control monitoring programs for clean rooms fulfill regulatory requirements from relevant standards.
Microbial trending and monitoring of environment and products meet appropriate ISO standards, i.e. ISO 11737, etc.
Key Responsibilities:
General:
- To assist to Quality Management in the implementation of the requirements into the quality system according to ISO 13485 standard & CGMP Quality System Regulation, and in compliance with relevant standards for areas under his/her responsibility.
- To participate in projects and Corrective and Preventive Actions relative to relevant areas (clean room, microbiological tests, etc.) under his/her responsibility.
- To take preventive and corrective actions for non-conformities detected.
Clean Room:
- To develop and ensure Hygiene monitoring is performed and proper actions is taken when necessary.
- To ensure that environmental and microbiological monitoring is in compliance with current regulatory requirements, and proper actions are taken when necessary.
- To secure adequate clean room classification.
- To review Pest Control activities and take proper actions when necessary.
- To participate on the Training/Re-training programs related quality area in relation to hygienic and monitoring, sterilization, awareness, etc.
- To collect and keep the hygienic, monitoring and sterilization records in accordance with the relevant rules.
- To follow up and update the procedures, work instructions and records of the area to ensure their compliance with current or updated relevant standards.
- Collaborate in other activities when is requested by the immediate superior.
- To comply with the company quality policy
- Communicate with suppliers of environmental monitoring services
Skills & Experience:
- Familiar/knowledge of GMP's and ISO 13485 or similar regulations preferred
- Familiar/knowledge on regulations related to Clean rooms (ISO 14644), or/and tests (Bioburden, LAL) required
- Min.1 year experience on medical devices environment, required.
- Experience on the handling of laboratory equipment
- Experience on the sampling and result controls of them and take decisions by their analysis
- Ability to work with other areas and other sites
- Ability to handle high pressure situations
- Strong English written and verbal skills, required
- Basic computer skills
Qualifications/Education:
- Professional career according with position (Chemical, Biochemical, Microbiologist, etc.)
Our transformation will change your career. For good. You’ll be pushed to think bigger and aim for excellence. Your ideas will be heard, and you’ll be supported to bring them to life. There’ll be challenges. But, stretch yourself and embrace the opportunities, and you could make your biggest impact yet. This is stepping outside of your comfort zone.
This is work that’ll move you.
#LI-AN1
#LI-Hybrid
Beware of scams online or from individuals claiming to represent Convatec
A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.
If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at [email protected].
Equal opportunities
Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.
Notice to Agency and Search Firm Representatives
Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
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If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View "Convatec Internal Career Site - Find Jobs". Thank you!
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What We Do
At Convatec, #ForeverCaring is our promise to patients & healthcare providers, as we deliver pioneering trusted medical solutions to improve the lives we touch.
