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Job Description
Explore your next opportunity at a Fortune Global 500 organization. Envision innovative possibilities, experience our rewarding culture, and work with talented teams that help you become better every day. We know what it takes to lead UPS into tomorrow—people with a unique combination of skill + passion. If you have the qualities and drive to lead yourself or teams, there are roles ready to cultivate your skills and take you to the next level.
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:
UPS is committed to providing a workplace free of discrimination, harassment, and retaliation.
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