Quality Compliance Coordinator (Temp.)

Job DescriptionMajor 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.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)Key Performance IndicatorsEnsures 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 Minimum RequirementsWork Experience:QC/ QA in pharmaceutical ind./ biotech with environmental monitoring &.cleanliness zones.Functional BreadthSkillsAction 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.Compliance requirements.LanguagesEnglish.