Job Description Summary

-Manages Quality aspects and projects within area of responsibility. -Ensures and supports overall GxP conformity and Compliance with the Sandoz Quality Management Systems.  
Job Description Summary
Supports effective GxP Compliance and/or Audit activities, operations and systems to ensure compliance of business areas with the Sandoz Quality Manual and Policies and all relevant GxP, legal and regulatory requirements, and through internal audits, KPIs (Key Performance Indicators) and KQIs (Key Quality Indicators)

Job Description

Job Description

Major accountabilities:

• Supporting all compliance activities including SQM, PQR, DMS,CHANGE, training, archiving, audits, recall etc.

• 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.

Skills Desired

Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence