Quality Systems Coordinator

Embecta Corp.; Ireland; Remote; EUR 40.000 - 64.000; Vollzeit

Zusammenfassung

Embecta Corp. in Ireland seeks a detail-oriented quality professional to manage batch records and document control. You will drive document revisions and maintain site documentation systems to support product release and audit readiness in a highly regulated manufacturing setting.

The role requires at least 2 years in medical devices or pharmaceutical manufacturing, experience with QMS, and familiarity with electronic systems including Batch Control, Document Control, and SAP preferred.

Qualifikationen

• 2+ years experience in Medical Devices or Pharmaceutical manufacturing.
• Experience with Quality Management Systems (QMS).
• Experience with electronic QMS including Batch Control and Document Control; SAP preferred.

Aufgaben

• Review batch records and ensure documentation complies with approved procedures.
• Coordinate document revisions and maintain the site’s Documentation System.
• Support product release and audit readiness in a regulated manufacturing environment.
• Record batch record review results in the complaint management system.
• Prepare technical documentation including product certifications for worldwide distribution.
• Support site audit activities for Regulatory and Customer audits.

Kenntnisse

Interpersonal skills

Communication skills

Teamwork

Attention to detail

Willingness to learn

Ausbildung

Science/Engineering degree

Tools

SAP

Jobbeschreibung

embecta is a global medical device company with a 100-year legacy in insulin delivery and diabetes care. Driven by innovation, purpose, and a commitment to improving lives, we are expanding our portfolio of solutions to serve even more patients, healthcare providers, and communities around the world. An excellent opportunity for a detail-oriented quality professional with document control experience to manage batch records, drive document revisions, and maintain site documentation systems. You'll work cross-functionally to support compliance, product release, and audit readiness in a highly regulated manufacturing setting.**Responsibilities:*** Work with cross-functional teams to support product release.* Perform timely review of batch records and associated documentation to ensure accuracy and compliance with approved procedures.* Track batch record review metrics and support continuous improvement initiatives* Be a key part of the coordination and maintenance of the site’s Documentation System leading document change requests and supporting stakeholders through the document revision process.* Maintain all batch history records and related documentation.* Record and maintain batch record review results in the complaint management system, ensuring quality events are appropriately documented and tracked* Prepare technical documentation including product certification to support worldwide product distribution.* Be a key member of the site audit team, supporting all Regulatory and Customer audits.* Provide support for the Quality Management System as determined necessary by Quality Management.**Educational Requirements and Relevant Experience:*** Science/Engineering qualification* A minimum of 2 years experience working in Medical Devices or Pharmaceutical manufacturing environment.* Experience working within an established Quality System* Experience with electronic Quality Management Systems including Batch Control and Document Control ideally with SAP or similar experience.**Knowledge, Skills and Abilities:*** Excellent interpersonal and communication skills* The ability to work progressively as part of a team and on own initiative* Eager to learn and follow direction* Excellent attention to detail#LI-DF1#LI-ONSITEembecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.