Operations Expert
- دبي
- دائم
- دوام كامل
- 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
- 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.