SUPPLIER AUDIT SPECIALIST (PHARMACEUTICAL)

HUMAN KAPİTAL İnsan Kaynakları ve Danışmanlık Hiz.Ltd.; Fatih; On-site; TRY 350,000 - 520,000; Full time

Job summary

HUMAN KAPİTAL İnsan Kaynakları ve Danışmanlık Hiz.Ltd. seeks a Supplier Audit Specialist for a leading contract pharma manufacturer. The role focuses on planning, conducting, and reporting supplier audits of materials, services, and subcontractors at the production facility.

Strong QA background in GMP/GDP/ICH, risk-based auditing, and CAPA management is required, with English fluency and willingness to travel up to 40% internationally.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biology, Chemical Engineering, Biomedical Engineering, or related field.
• Minimum 3 years of active supplier auditing experience in pharma QA.
• Fluent in English (written and spoken) to manage international audits and stakeholders.

Responsibilities

• Audit planning, preparation, risk assessments, and supplier evaluations.
• Conduct on-site supplier audits for raw materials, services, and subcontractors.
• Prepare detailed audit reports and manage follow-up, evaluation, and closure.
• Coordinate CAPA processes and monitor effectiveness in quality systems.

Skills

QA in pharma

Supplier auditing

GMP/GDP/ICH

English fluency

Risk-based audits

Audit planning

CAPA management

Education

Bachelor’s degree in Pharmacy or related discipline

Tools

MS Office

Job description

SUPPLIER AUDIT SPECIALIST (PHARMACEUTICAL)

On behalf of our client—one of the world's largest independent contract manufacturing companies in the pharmaceutical sector with foreign capital and a strong corporate presence, we are seeking a Supplier Audit Specialist to be based at their production facility.

QUALIFICATIONS

Education & Experience:

• Bachelor’s degree in Pharmacy, Chemistry, Biology, Chemical Engineering, Biomedical Engineering, or a related discipline,
• Proven experience in Quality Assurance (QA) within the pharmaceutical industry, with at least 3 years of active experience in supplier auditing,
• Fluency in English (both written and spoken) to effectively manage international audits and global stakeholder relations.

Technical & Professional Competencies:

• Strong knowledge of GMP, GDP, ICH guidelines, and relevant regulatory requirements,
• Hands-on experience with risk-based audit methodologies and practices,
• Solid understanding of Quality Management Systems (ISO 9001, ISO 13485), CAPA, and document control procedures,
• Experience in statistical process control and data analysis, with proficiency in MS Office applications,
• Preferred: Lead Auditor Certification (GxP, ISO 9001, etc.) and experience working with international suppliers.

Personal Skills & Working Conditions:

• Strong analytical, detail-oriented, and problem-solving mindset,
• Excellent interpersonal, persuasion, and stakeholder management skills,
• High ethical standards, independent decision-making capabilities, and strong stress management,
• Willingness and availability to travel nationally and internationally (up to 40% travel requirement),
• Ability to work in a manufacturing environment, wear PPE, and adapt to cross-cultural work environments,
• Completed military service for male candidates; valid driver's license preferred.

JOB DESCRIPTION

Audit Planning & Preparation:

• Prepare, update, and implement annual supplier audit plans and risk-based audit frequencies; allocate required resources,
• Develop audit agendas, operational plans, and perform pre-audit risk assessments and supplier evaluations.

Audit Execution & Reporting:

• Conduct on-site supplier audits for raw materials, service providers, and subcontractors,
• Prepare detailed audit reports and manage follow-up, evaluation, and closure processes.

CAPA & Quality System Management:

• Coordinate Corrective and Preventive Action (CAPA) processes, open CAPA records, monitor implementation, and verify effectiveness.

Quality Systems & Qualification Support:

• Support supplier qualification/requalification processes, monitor supplier KPIs, and assist in managing quality disputes,
• Contribute to updating SOPs, audit procedures, and support official authority, customer, or internal audits,
• Maintain auditor qualifications and active certified status.