Acino International AG
QMS Specialist - Training & Data Integrity
Acino International AG, Egypt, Pennsylvania, United States
Overview
Arcera is a global life sciences company headquartered in Abu Dhabi, United Arab Emirates. Our purpose is to enable longer and healthier lives while creating sustainable growth. We develop, manufacture, and commercialize a broad range of high-quality innovative and proven medicines in key international markets. With a large footprint reaching patients in over 120 markets, and manufacturing and packaging facilities in eight countries, we offer more than 2,000 medicines across various therapeutic areas worldwide. The companies Acino, Amoun, Birgi Mefar Group, and M8 are all part of Arcera Life Sciences.
Responsibilities
Manage and continuously improve QMS processes for training and archiving.
Ensure all training records and documentation archives are maintained in compliance with GMP, GDP, and company policies.
Develop, implement, and monitor training programs for quality and compliance topics.
Oversee the lifecycle management of quality documents, ensuring timely archiving and retrieval.
Coordinate CCS (contamination control strategy) activities.
Act as the organizational champion for Data Integrity, promoting DI principles and best practices.
Lead DI awareness campaigns and training sessions for staff at all levels.
Monitor DI compliance and support investigations of DI-related deviations or incidents.
Collaborate with IT and QA to ensure systems and processes support DI requirements.
Coordinate and deliver training on QMS, DI, and related quality topics.
Maintain training matrices and ensure training compliance for all relevant personnel.
Evaluate training effectiveness and implement improvements as needed.
Oversee the archiving of quality documents, ensuring compliance with regulatory and internal retention requirements.
Support audits and inspections by providing timely access to archived records.
Identify and implement process improvements in training, archiving, and DI.
Support internal and external audits, ensuring readiness and compliance in assigned areas.
Escalate quality or compliance issues as per company procedures.
Work closely with QA, IT, HR, and other departments to ensure alignment and integration of QMS, training, and DI initiatives.
Serve as a resource for QMS, training, and DI-related queries and projects.
Qualifications
Degree in Life Sciences, Pharmacy, Chemistry, or related field; advanced degree preferred.
3+ years’ experience in pharmaceutical quality management systems, with a focus on training, documentation, or data integrity.
Experience in developing and delivering training programs.
Strong knowledge of GMP, GDP, and DI requirements.
Experience with electronic documentation and learning management systems.
Audit support experience is a plus.
Excellent organizational and communication skills.
Proven ability to drive process improvements and foster a culture of quality and compliance.
This is an 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!
#J-18808-Ljbffr
Responsibilities
Manage and continuously improve QMS processes for training and archiving.
Ensure all training records and documentation archives are maintained in compliance with GMP, GDP, and company policies.
Develop, implement, and monitor training programs for quality and compliance topics.
Oversee the lifecycle management of quality documents, ensuring timely archiving and retrieval.
Coordinate CCS (contamination control strategy) activities.
Act as the organizational champion for Data Integrity, promoting DI principles and best practices.
Lead DI awareness campaigns and training sessions for staff at all levels.
Monitor DI compliance and support investigations of DI-related deviations or incidents.
Collaborate with IT and QA to ensure systems and processes support DI requirements.
Coordinate and deliver training on QMS, DI, and related quality topics.
Maintain training matrices and ensure training compliance for all relevant personnel.
Evaluate training effectiveness and implement improvements as needed.
Oversee the archiving of quality documents, ensuring compliance with regulatory and internal retention requirements.
Support audits and inspections by providing timely access to archived records.
Identify and implement process improvements in training, archiving, and DI.
Support internal and external audits, ensuring readiness and compliance in assigned areas.
Escalate quality or compliance issues as per company procedures.
Work closely with QA, IT, HR, and other departments to ensure alignment and integration of QMS, training, and DI initiatives.
Serve as a resource for QMS, training, and DI-related queries and projects.
Qualifications
Degree in Life Sciences, Pharmacy, Chemistry, or related field; advanced degree preferred.
3+ years’ experience in pharmaceutical quality management systems, with a focus on training, documentation, or data integrity.
Experience in developing and delivering training programs.
Strong knowledge of GMP, GDP, and DI requirements.
Experience with electronic documentation and learning management systems.
Audit support experience is a plus.
Excellent organizational and communication skills.
Proven ability to drive process improvements and foster a culture of quality and compliance.
This is an 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!
#J-18808-Ljbffr