Global Quality GMP Auditor

Education and Experience:

Graduate of Pharmacy, Chemistry, Microbiology, Biochemistry University or another related science preferred with technical background;

At least 5 years experiences in Auditing in the Pharmaceutical Industry, ideally in the areas manufacture, quality control or quality assurance

Experience in auditing Third party contractors according to EU GMP Guideline Part I and Part II, Excipient Guideline (IPEC; Excipat) or equivalent (ICH Q7, national)

Advanced knowledge of GMP guidelines and requirements

Proven University track record as GMP /QA auditor

Fluent English skills

Excellent communication skills

Experience in Leadership

Team oriented, self-motivated, integer, agile, proactive

Good interpersonal skills, ability to work with all levels of personnel and management.

Good problem solving and risk assessment abilities.

Job description:

• Continuously assesses quality processes and systems in his area of responsibility to proactively identify compliance risks. Develops mitigation plans, ensures resourcing and timely execution
• Responsible for process excellence related to GMP Auditing.
• Continuously assesses and improves the performance of his function as reflected in global KPIs, to meet the requirements of regulatory authorities, company standards, external and internal customers with respect to compliance, quality, service, cycle time and costs
• Supports the vision and goals of the organization through effective decision making and the ability to drive change.
• Ensures that GMP for materials and services used for production of drug products comply with quality, product-specific and legal requirements by initially auditing and reauditing suppliers on a routine basis and within for cause actions
• Ensures proper planning and execution of external audits of suppliers for APIs, intermediates and finished products, excipients, primary and/or printed packaging material manufacturers, testing/releasing sites, warehouses and service providers, Contract Manufacturers, Contract Research Organization executed by own team to monitor that all aspects of the operational business comply with applicable GMP / GDP legal and regulatory requirements (. national and EU requirements),  and the STADA Group Quality Standard in close cooperation with the Global Vendor Qualification Team located at STADA Hemofarm SRL in Romania.
• Ensures proper distribution of audit reports, CAPA plan reviews incl. acceptance and audit closure will be performed in time and monitored with applicable KPIs
• Support qualification and requalification of auditors within STADA group by own team
• Provide technical guidance and support by discussion to QA auditors within STADA group and colleagues from Global Quality Supplier Qualification team in case of different audit experience/ observations/ compliance report / decision over audit closure / reaudit frequency to ensure overall quality and compliance.( Audit Closure )
• Participates in global projects and ensures timely implementation in global department

Benefits:

Attractive salary package;
The opportunity to develop a career in a multinational industrial group;

Please send your CV’s only in English