Operations Expert

Acino Pharma

Role Overview

The Quality Operations Expert will be responsible for overseeing in-process quality assurance (IPQA) activities across all stages of manufacturing. This includes ensuring strict adherence to Good Manufacturing Practices (GMP), safeguarding data integrity principles (ALCOA++), and proactively monitoring operations to identify and mitigate quality risks. The role plays a critical part in maintaining consistent product quality, safety, and efficacy while driving a culture of compliance and continuous improvement within the organization.

Main Tasks:

• To ensure that batch production operations are carried out in accordance with cGMPs and applicable regulations
• Monitoring of manufacturing/packing activities through IPQA activities on routine basis.
• Issuance of documents like batch manufacturing and packaging records etc.
• To review batch documents related to regulatory submission [batch records and associated data].
• To ensure good documentation by all the concerned and all the documents are as per current GMP requirements and in-house SOPs.
• To participate and ensure satisfactory and timely technology transfer, process validation and cleaning validation studies.
• Initiation, handling and review of non-conformances, deviation, change control, CAPA and Coordinate in absence of QMS coordinator.
• Preparation and review of Investigations related to Product complaints & ensure that appropriate measures are taken to prevent recurrence.
• To participate in audits and to provide relevant information, when required.
• Review of all GMP master documents like IMFPC, MFPC, Batch records.
• To ensure awareness of cGMP requirements are evaluated, updated through periodic training & carry out On the Job Training to the Shop Floor personnel.
• Responsible to ensure the execution of validation activity as per the annual validation and revalidation planner as per Validation Master Plan.
• Preparation and review of protocols and reports of process validation, Hold time and cleaning validation.
• Participate in execution of qualification and requalification activities as per scheduler.
• Preparation of Annual product review.
• Preparation of Standard operating procedure and provide training on SOPs

Qualifications & Skills:

• Master s or Bachelor s degree in Pharmaceutical Sciences.
• 8-10 years of progressive experience in In-Process Quality Assurance (IPQA) within the pharmaceutical industry.
• In-depth knowledge of oral solid dosage form (OSD) manufacturing processes and IPQA practices.
• Hands-on experience with electronic Quality Management Systems (eQMS), including modules such as TrackWise and IQVIA.
• Strong understanding of cGMP, GDP and Data Integrity principles aligned with ALCOA++.
• Exceptional attention to detail, with proven analytical, critical-thinking, and problem-solving abilities.
• Exposure of working with USFDA & EU approved facility in a similar role.
• Effective communicator with strong collaboration and teamwork capabilities, fostering cross-functional alignment.
• Flexible and resilient in managing dynamic work environments, shifting priorities, and cross-functional demands.

This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!

Please apply via our HR system here.