Job Posting Closing Date: 31st May 2023
Supply Chain Compliance Specialist:
Job Responsibilities:
General
- Ensure compliance with cGMP, corporate standards/Pfizer Quality System (PQS), Site policies/procedures, regulatory requirements and industry standards.
- Partner closely with customers and stakeholders to understand and deliver on all compliance requirements within timelines and escalate where necessary through the IMEx Material Supply Ecosystem infrastructure.
- Participate in cross-functional teams as required to provide consultative support on quality-related issues. Provide support with investigations and resolution of discrepancies e.g. Investigation Method 1’s etc. Assuring completeness in terms of root cause, action taken, and CAPA effectiveness.
- Authors, tracks, and review for adequacy, Procedures, investigations, commitments, change controls, forms, logbooks, protocols, and reports etc.
- Manage the rollout of the DI process in Supply Chain to assure compliance with corporate requirements.
- Responsible for the running, management and co-ordination of the following important forums on behalf of the Supply Chain team;
- Weekly Change Review Panel (CRP)
- Local Site Inspection Readiness Committee (SISC) and Cross-site SISC.
- Weekly Supply Chain QTS System meeting
- Quarterly Deviation Trending process as part of the SQRT.
- Support & guide Supply Chain project teams from a compliance perspective to ensure robust project execution and delivery of value.
Inspection/Audit
- Ensure inspection readiness program is functioning effectively.
- Carry out cGMP compliance process and area walks.
- Support and participate in Internal Quality audits as per the site inspection calendar.
- Preparation, Support and participate in all Board of Health and Regulatory Inspections
- Review and approve internal audit reports and co-ordinate Regulatory and Board of Health Audit responses as required.
- Network
- Create Supply Chain compliance community of practice and/or common interest groups to leverage and share across our Biotech network
- Participate in forums required to support the operation of Quality systems/processes.
Zero Defects:
- Support the Site Zero Defects program achieving the repeat deviations transformation metrics.
- Achieve 10% repeat QAR's/Month (CAPA effectiveness measure}
- Create ZD process and embed into SC Dept.
- Deployment of PHP where appropriate.
IMEx Support
- Support IMEx Material Supply Ecosystem through participation in
- Tier 1 & Tier 2 huddles
- CI processes
- Gemba
People / Values
- Demonstrate the GC OWNIT values.
- Adhere to all HR Policies as appropriate
- CI tools/- capability is a key building block for learning & development - positive engagement with key stakeholders.
- Best practices developed and shared with other teams /sites.
- Best practices actively sought and copied.
- Proactive & effective communication within and across Supply Chain.
Education/Experience
- Preferred Third Level Qualification or Equivalent.
- Previous Quality experience as detailed in the job responsibilities section, within a cGMP environment in a Pharma/Biotech company
- Excellent communications and interpersonal skills
Additional Information
- In order to be considered for this position in Ireland you need to be legally eligible to work in Ireland.
- Please note there is no relocation support available for this position
How to apply
- Make a difference today, all suitable candidates should apply with CV below. We are looking forward to hearing from you!
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
