Operations Compliance & GMP Expert

• Control and enforcement of GMP and SOP guidelines, including independently determining necessary actions to fulfil these responsibilities.
• Establish Quality KPI for the production performance and update in weekly basis.
• Preparation, support, and follow-up of regulatory inspections, audits, and self-inspections.
• Handling and documentation of deviations and complaints, both internal and external.
• Evaluation of deviations and complaints, with recommendations for resolution in coordination with relevant departments.
• Initiation and processing of CAPAs (Corrective and Preventive Actions) in production.
• Documentation and management of observations and findings from internal and external audits (self-inspections, customer audits, and regulatory inspections).
• Frontline support for manufacturing, collaborating with shift teams to ensure the safe production of each batch in compliance with batch instructions and quality standards.
• Implementation of process improvements and scale-up activities.
• Ensuring process-related batches generate sufficient process knowledge through thorough testing of critical variables.
• Leading investigations into product and process deviations, including complaints, expectation mismatches, and specification deviations.
• Applying scientific and statistical methods to analyse data, understand processes, and identify root causes of product and process failures.
• Ensuring all critical and significant parameters are documented in appropriate instructions (e.g., Master Batch Record, Validation Plan).
• Immediate escalation of quality-related events to supervisory authorities.
• Creation, revision, and training of SOPs in production.
• Initiation and, when necessary, delivery of SOP and Data Integrity training.
• Conducting and documenting employee training sessions, such as those related to complaints or deviations.
• Continuous development and enhancement of quality management in production.
• Organization and execution of internal Gemba Walks.
• Coordination and execution of quality-related projects.
• Ensuring compliance and cost reduction related to quality issues or recurring deviations.
• Promoting safety through execution of internal CAPAs focused on safety improvements or potential risks.
• Encouraging and collecting ideas for continuous improvement.
• Creation and revision of change controls.

• Bachelor’s degree in pharmaceuticals sciences.
• At least 3 years of experience in the GMP environment, EU GMP operation environment relevant operation and qualification background.
• Relevant experience in the GMP environment / Pharmaceutical company preferred Multinational culture and EU GMP background
• Cross-departmental thinking
• Communicative and team-oriented personality
• Team player
• Good user knowledge of MS Office programs, SAP, TrackWise, etc.
• Extensive pharmaceutical process knowledge, as well as knowledge of the methods used in manufacturing and testing
• Team orientation, competence, commitment, sense of responsibility, assertiveness, structured, independent, and solution-oriented work style, flexibility, initiative.

Acino