Junior GMP Specialist

Department: Quality

Job Summary

• In this role within Quality assurance department, you will be responsible for maintaining compliance with GMP standards and management of computerized systems, verified Excel Spreadsheets, electronic raw data, etc.
• This role will include the involvement in the Global Data Integrity program (DI) and local execution of the project plan.
• You will facilitate creation of local procedures on relevant DI and GMP topics and support all affected functions in their implementation (Computerized System Validations, Excel Spreadsheet verifications, Archiving of electronic raw data etc.).

Essential Duties and Responsibilities

• Assures local site’s compliance with current Good Manufacturing Practice (cGMP) and Data Integrity (DI) standards within the organization.
• Supports all relevant functions as West´s local Subject Matter Expert (SME) on DI.
• Ensures that the documentation in the laboratories follows cGMP standards and support the Laboratories in the administration of the documents and electronic systems.
• Provides support regarding cGMP compliance during projects such as method validation, method transfer, instrument qualification and verification of Compendial Test Methods.
• Provides functional expertise and advice for proper calibration of analytical instruments, verification of Excel Spreadsheets, set-up of computerized systems, etc.
• Facilitates creation of local procedures on relevant DI topics and support all affected functions in their implementation (Computerized System Validations, Excel Spreadsheet verifications, archiving of electronic raw data etc.)
• Supports all affected functions in bringing their systems and processes into compliance with GMP and DI principles and in maintaining that state.
• Deploys communication strategy for typical customer questions on DI (during audits), and educates the relevant functions accordingly (Quality, Laboratory, Operations).
• Training of West staff in DI and GMP relevant topics.
• Conducts audits to ensure the identified key quality data points are entered and maintained at a GMP level across the modules such as OOS / CAPA / Audits / Deviation and Complaints.
• Performs regular data audits of laboratory’s test results.
• Supports and guide QA continuous improvement projects.
• Works in compliance with the relevant procedures, ISO 9001 and ISO15378 requirements.
• Reports DI status to DI program manager and site QA manager.

Your Profile

• Scientific bachelor’s degree - Technological, Chemical or other nature science faculty.
• At least 2 years of professional experience in a cGMP environment

Preferred Knowledge, Skills and Abilities

• English spoken and written (high level)
• Detail-focused person
• Ability to work in a diverse, cross-functional team
• Following will be considered as an advantage

• • Experience at a similar position, preferably in medical, pharmaceutical or food processing industry
  • Experience with SAP QM and other Laboratory related applications
  • Experience in Lab Instrumentation / IT Experience

We Offer

• A dynamic international working environment
• Excellent working conditions
• Organized transportation to and from Kovin for employees residing in Belgrade and Pančevo
• Opportunities for personal and professional growth
• Access to a modern and comprehensive learning management system
• A well-equipped canteen offering freshly prepared meals
• A supportive and collaborative team environment
• Private health insurance
• A competitive salary and benefits package