Job Purpose

Provide specialist support in the areas of compliance and implementation of the Novartis Quality Management System to ensure all activities related to both site and product are compliant with cGxP requirements (incl. data integrity), Novartis internal quality standards, and relevant international and local regulatory requirements.

Major Accountabilities

Operational

· Ensure all activities in compliance with cGxP, incl. data integrity

· Support site qualification and validation activities (planning, advising, review)

· Documentation management (incl. archiving)

· Preparation/support and coordination of CAPA/follow-up

· Audit and inspection preparation and support

· Change control review/approval (routine changes)

· Ensure local DI and eCompliance oversight (training, inspections, plan, risk ID etc.)

· Ensure process quality assurance acc. to regulations

· KPI trending

HSE

· Comply with all HSE guidelines

· Detect and report potential accident, risks and propose solutions

· Participate in HSE risk assessments

· Preparation and participation to internal HSE audits

· Responsible for participating in initial training and retraining

Key Performance Indicators 

· 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

Dimensions of the Job

Impact on the organization

Direct impact on Quality, compliance, and product timely delivery

Ideal Background 

Relevant Experience

· Experience in pharmaceutical quality control, quality assurance or production

Education & Qualification

· University degree with a scientific / technological background (e.g. Chemistry, Pharmacy, Biology, Biochemistry, or equivalent)

Languages

Good (oral and written) in English; fluent in local language (oral and written)

Competencies

· Collaboration; result-oriented

· Operational Excellence; Continuous Learning; Digital & Tech Savvy; Being Resilient

· MS Office applications and other standard IT applications supporting Quality activities

· Quality Assurance; Knowledge of GMP; Quality Standards

· Technological competence; Quality Assurance; Knowledge of GMP, Quality Standards; Technological competence; action oriented; functional professional skills; optimize work processes