Operations Compliance & GMP Expert

The Position

The Role

The Operations Compliance & GMP Expert will be responsible for overseeing and enforcing GMP and SOP compliance within production, ensuring independent decision-making to maintain quality standards. Establishes and tracks Quality KPIs on a weekly basis to monitor production performance. Prepares for and supports regulatory inspections, audits, and self-inspections, while managing deviations, complaints, CAPAs, and change controls.

Your Opportunities

• 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.

Who You Are

• 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.

We Are Acino

At Acino, we push the boundaries to deliver high-quality pharmaceutical products that improve patients’ lives. Driven by our collective purpose to provide access to medicines to those in need, our strength lies in our unique expertise and presence in emerging and high-growth markets. We are proud to be challenging the status quo in the pharmaceutical industry, always looking ahead to the future with an open mind.

Join Acino, a dynamic and rapidly growing environment where your contributions can make a real difference.

Acino is an Equal Opportunity Employer.

How To Apply

Please apply via our HR system here. Only direct applications will be considered