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Quality Compliance Coordinator (Temp.)
JOB_REQUIREMENTS
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Salary
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Job Description
Major accountabilities:
Work Experience:
Major accountabilities:
- Planning and supporting PQR/APQR activities -Support site qualification and validation activities (planning, advising, review) -Implementation of Quality Systems (incl. documentation management) -Supplier management activities (agreements, oversight, audit) -Preparation/support and coordination of CAPA/follow-up -Audit and inspection preparation and support -Change control review/approval -Ensure local DI and eCompliance oversight (training, inspections, plan, risk ID etc.) -Ensure process quality assurance acc.
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to regulations -QP declaration review and approval -KPI trending -Ensure applications, certificate maintenance etc. to local HA -SPOC for communication with HA, GCA / One voice / consolidated approach / synergies for all sites within same HA jurisdiction / country -Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products within 24 hours of receipt -Distribution of marketing samples (where applicable)
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Ensures planning and successfully supports PQR/APQR activities -Successfully carries out site qualification and validation activities (planning, advising, review) -Supports the implementation of Quality Systems (incl. documentation management); Ensure local DI and eCompliance oversight (training, inspections, plan, risk ID etc.) -Ensure process quality assurance according to regulations
Work Experience:
- QC/ QA in pharmaceutical ind./ biotech with environmental monitoring &.
- cleanliness zones.
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Functional Breadth
- Action Oriented.
- Continuous Learning.
- Dealing With Ambiguity.
- Functional Skills.
- Gmp Procedures.
- Process Optimization.
- QA (Quality Assurance).
- Quality Standards.
- Self-Awareness.
- Technological Expertise.
- Technological Intelligence.
- GxP.
- Industry standards.
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Compliance requirements.
- English.
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