...core member of the GO team and will be responsible for measuring, monitoring, and developing action plans related to Quality Brand Health.
Key Responsibilities
As an Individual contributor:
Serve as the core Quality member of the global Operations team (GO) as...
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Remote job
Schichtarbeit
...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
...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
...actions (CAPA) and Effectiveness Checks.
Promotes safe practices and behaviors.
Reports 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
..., 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
...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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...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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...Responsibility for all vigilance duties pursuant to current regulations (today they are: EEC/93/42, (EU) 2017/745, ISO 13485, MDSAP, FDA-QSA, Health Canada, etc.)
• Guarantee of compliance of all BIOPTRON products in all requested countries
• Keeping up to date with changes in...
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