Quality Compliance Coordinator (Temp.)

Biopharma Careers; Gebze; On-site; TRY 350,000 - 520,000; Full time

Job summary

Biopharma Careers is seeking a Quality/QA professional in Gebze to ensure GxP compliance and scalable quality systems across site activities. You will coordinate audits, CAPA and supplier oversight while supporting change control and documentation management.

Experience in pharma/biotech QA, environmental monitoring, and regulatory liaison is essential for success in this role and for ensuring timely responses to inspections and HA communications.

Qualifications

• QC/QA experience in pharmaceutical ind./biotech with environmental monitoring and clean zones.
• Experience implementing GMP/GxP compliance and quality systems.
• Audit, CAPA and inspections experience.

Responsibilities

• Support 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)

Skills

Action Oriented

Continuous Learning

Dealing With Ambiguity

Gmp Procedures

Process Optimization

QA (Quality Assurance)

Quality Standards

Self-Awareness

Technological Expertise

Technological Intelligence

GxP

Industry standards

Compliance requirements

Job description

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