Quality Compliance Coordinator (Temp.)

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.

• 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 indicators:

• 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

Minimum Requirements:

Work Experience:

• QC/ QA in pharmaceutical ind./ biotech with environmental monitoring &.

• cleanliness zones.

• Functional Breadth

Skills:

• 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.

• Compliance requirements.

Languages:

• English.