Kenny-Whelan (a specialist division of the CPL group) are hiring a Quality and Compliance Specialist (Supplier Quality) to support 2 sites for one of our Global Pharma/Biopharma clients in Cork.
Contact Jenn Dinan on 0860466583 or email [email protected]kenny-whelan.ie
Quality Specialist – Supplier Quality
To cover Barnahely & Little Island
Quality and Compliance specialist ensuring quality standards are achieved and maintained at suppliers through supporting management, and oversight on Quality Operations functions for external business partners.
This support includes ensuring continuous compliance with relevant regulatory health authority requirements, effective risk management, strategy development and execution, and effective collaboration between R&D, Operations, Procurement, TechOps, Regulatory Affairs and other technical disciplines (EHS). Functions and activities include quality assurance review functions (such as Change Control, Quality Issue Management, compliance audit activities, supporting creation and management of risk mitigation plans for suppliers.
Quality Specialist supports ensuring business, quality and compliance goals adhere to J&J policies, enterprise standards and government-issued environmental, health, safety, quality and regulatory policies and guidelines. Represents the JNJ credo and quality values in contact with the suppliers and will comply with the JNJ regulations for ethic and business conduct in order to strengthen the reputation of J&J.
This position requires the ability of building collaboration and teamwork across the local and global JSC organization, and it interfaces JSC ESI Quality with the quality unit of suppliers.
This position acts as a supporting role, supporting single point of contact support to JSC LM sites.
- 3 years of experience in quality management, production, quality control, or R&D in a pharmaceutical and/or biotechnology environment
- Familiar with GMP – and International Conference on Harmonization ( ICH ) – regulation
- Trackwise and SAP experience would be desirable
- Exposure to regulatory authorities’ inspections
LIST JOB SPECIFIC COMPETENCIES/SKILLS REQUIRED:
Support of planning, execution, and documentation of the qualification and monitoring for suppliers who are sourcing APIs, API materials or DP materials such as excipients, raw or packaging materials, to the Janssen Supply Chain for the manufacture of Intermediates, APIs, or drug products respectively
Support Surveillance on the quality and compliance status for all suppliers of raw materials, packaging materials, intermediates, excipients, and APIs.
- Support of Management of Change related to supplier (change assessor, action executioner,)
- Assessment of deviations, corrective and preventative actions (CAPAs), and complaints concerning materials received from suppliers
- Provision of all information needed for the release/reject of suppliers in SAP (SAP master data) and SAP Material approval /AML updates for LM.
- Support Establishment of Quality requirements and Quality agreements and periodic review of Quality Agreements
- Support account owners for initial assessment and qualification of suppliers for new product introductions, and establishment of initial Qualification Statements
- Support Periodic performance measurement for suppliers
- Provide support to JSC local Site during Customer and HA inspections as needed
- Support supplier Specification agreement and approval management
In conjunction with Account owners he/she collaborates with internal operating companies and R&D partners on a wide variety of product, process, project and compliance related issues. Interfaces with internal JSC functional groups to broker the necessary technical support for external partners. Interactions are required with Tech Ops, PDMS, Procurement, EHS, Planning, the different JSC manufacturing sites, but also with the other quality groups within JSC and on enterprise level, such as Compliance, Quality unit API manufacturing, Quality systems and the different Qualified persons.
All application will be treated with the strictest of confidence.
Contact Jenn Dinan on 0860466583