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Job Description:
General
* Monitors and ensures compliance to UPS SCS site regulatory license requirements (e.g., GMP, GDP, ISO).
* Provides regulatory guidance to client and internal staff.
* Responds to client quality department inquiries or concerns.
* Assesses quality risks and develops corrective and preventative actions (CAPA) to close identified gaps or concerns.
* Supports the prompt execution of recalls and other market actions.
* Creates, revise and reviews controlled documents and record templates (e.g. SOPs, Work Instructions, forms and manuals).
* Supports change control management.
* Initiates, assesses and approves change controls.
* Develops quality related change action plan(s) and tracks to closure.
* Facilitates audits (regulatory agency, client/external and internal).
* Supports Continuous quality management system improvements.
* Conducts quality management system reviews.
* Provides support of investigation for non-conformance and customer complaints.
* Supports the qualification of all applicable vendors and suppliers.
* Monitors and provides direction for control of environmental storage conditions (e.g. refrigeration, freezer).
* Reviews, assesses and approves facility validation protocols and reports.
* Facilitates site employee training.
* Interface with senior QA management and senior operations management.
Responsible Person
* The Responsible Person is designated by the wholesale distributor, European Union (EU) Good Distribution Practices (GDP) license holder (Article 79 of EU Directive 2001/83/EC).
* This position further describes in EU GDP of Medicinal Products for Human Use (2013/C 343/01) of 05 November 2013.
* United Parcel Service (UPS) Supply Chain Solutions (SCS) has given the Responsible Person defined authority, resources, and responsibility needed to fulfill his/her duties.
* This position represents UPS Healthcare for wholesale distribution activities of medicinal products.
* The Responsible Person carries out duties in such a way as to ensure the wholesale distributor can demonstrate GDP compliance and public service obligations are met.
* He/She may delegate his/her duties (not responsibilities) when absent and keeps appropriate records relating to any delegation.
* The Responsible Person fulfills his/her responsibilities personally and is continuously contactable. The RP will be approved by the national competent body (HPRA)
Leadership
* Manages and supports development of HC QA Specialist and administrative staff.
* Uses career development tools.
* Provides feedback and direction.
* Next-level escalation for HC QA Specialists.
* Interface with site management.
Knowledge/Experience
* Bachelor’s degree in science related discipline preferred
* 3 to 5 years’ experience in pharmaceutical or healthcare industry in a quality related role
* Strong technical quality and regulatory affairs (QA/RA) knowledge
* Experience with GMP and GDP guidelines
* Experience with ISO 13485 and 90001 standards
Skills/Attributes
* Proficiency in English required (written and verbal)
* Experience in managing staff
* Positive leadership, influence and negotiation skills
* Strong verbal and written communication
* Strong organization, time management and planning
* Superior attention to detail
* Agility and Flexibility
* Must be RP eligible
Employee Type:
Permanent
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