...for post-approval filings, annual reports, product renewals, Annual Product Stability Reviews, and stability related responses to health authority inquiries
Serves as stability representative for OOT/OOS investigations, Market Action Fact Finding, and other investigations...
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Temporär
...procedures.
Perform peer review as needed.
Promotes safe practices and behaviors:
Report immediately incidents to Environmental, Health and Safety department; participate in investigations and identify measures to prevent similar accidents in the future....
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Soforteinstellung
Remote job
Schichtarbeit
...acceptance tests) and SAT (site acceptance tests) tests and commissioning of automated systems.
Respect and promote the EHS (environment, health, safety) rules in force on the site and participate in the improvement of the intervention conditions by a proactive attitude....
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Soforteinstellung
...factory acceptance tests) and SAT (site acceptance tests) and commission automated systems.
Promote and adhere to EHS (environment, health, safety) rules on site, contributing to the improvement of intervention conditions through a proactive attitude.
If you are...
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...cGxP requirements and best practices, including 21 CFR part 11, 210 and 211, Annex 11, EU-GMP guidelines and CAMP
Experienced in Health Authority inspections (preparation, process, presentations, responses drafting, etc).
Knowledge of pharmaceutical facilities,...
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Your future job
Melexis is actively exploring new biosensor technologies for digital health applications in wearables, remote patient monitoring and in-vitro diagnostics (www.melexis.com/digital-health). As a Sensor Design Engineer at Melexis, you will drive the design...
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Remote job
..., or bulk/QC and cGMP compliance related issues. Additional tasks are quality metrics, risk assessments, as well as the support of health authorities’ inspections and corporate audits.
This position will be working closely with the QA Operations management to identify...
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Schichtarbeit
Spätschicht
...and manage conflicts.
Foster creativity and promote teamwork.
Enforce rules and discipline (internal regulations), as well as health and safety regulations.
HOW WILL YOU EXPERIENCE SUCCESS
You possess either a master's degree in business or industrial...
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...for post-approval filings, annual reports, product renewals, Annual Product Stability Reviews, and stability related responses to health authority inquiries.
• Serve as stability representative for OOT/OOS investigations, Market Action Fact Finding, and other investigations...
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...identification and corrective/preventive actions to of any deficiencies identified during new product method transfer and audits (internal, health authority, customer), and provide, if needed, support to resolution of deficiencies occurring during manufacturing, utilities...
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