Urgent Search: Quality Assurance Specialist – External Manufacturing

Quality Assurance Specialist – External Manufacturing (Remote)

- Industry Pharma/Biotech/Clinical Research
- Work Experience 4-5 years
- City Dublin
- State/Province Dublin
- Country Ireland

Job Description

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide. We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients.

'Take your Careerto a new Level'

PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.

Employee ValueProposition

Employees are the "heartbeat" of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression. We believe in creating high performing teams that can exceed ourclient's expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.

Overview:

- The Manufacturing & Supply Division of our company isdedicated to being the most trusted supplier of biopharmaceuticals worldwide.Our facilities, along with our external contractors, suppliers, and partners,create a reliable global manufacturing network that's devoted to delivering ahigh-quality, reliable supply to customers and patients on time, every time.

- Our Quality Assurance group ensures every single materialinside our products is manufactured, processed, tested, packaged, stored anddistributed aligned with our incredibly high standards of quality and meets allregulatory requirements. Partnering across our internal manufacturingfacilities, external contract manufacturers and suppliers we create aninterdependent global manufacturing network dedicated to deliver a compliant,reliable supply to customers and patients on time, every time, across theglobe.

- The Specialist – External Quality Vaccines acts asProduct Quality Manager (PQM), responsible for ensuring that all our productsmanaged by External Quality Assurance (EQA) are manufactured, packaged,analysed, released, stored, and distributed in accordance with our expectationsand all applicable regulatory requirements. The role has primary batch releaseresponsibility and ensures that effective and robust Quality systems are inplace to comply with required regulations, policies and guidelines governingthe External Partners (EP/ExP's) manufacture and release of vaccine drugsubstance and drug products by means of risk-based quality oversight andon-site supervision, as appropriate.

- This is a 6 months Contract role.

Requirements

Role Functions:

- Evaluate and/or release products to other sites and/or tothe market with the assurance that the goods were produced in conformance toall applicable policies/procedures and compliance with all governingregulations

- Review and approve change controls

- Manage routine and complex deviations and complaints andassist in the coordination of significant investigations

- Conduct routine and solve complex analytical changerequests and support process modification change controls

- Stability Program management, including review ofstability reports, and Annual Product Review assembly

- Provide on-site guidance in the preparation of metrics,procedures, and guidelines

- Track and monitor operational and quality performance ofthe EP/ExP and can work with supplier to develop Corrective and preventiveaction (CAPA) plans

- Assist the maintenance of retention samples, shipreagents and samples to support licensure and foreign registration

- Support routine process validation; review and approvevalidation reports/tech transfer

- Prepare pre-PAI assessments, support document requestsfor regulatory filings and post approval changes

Experience,Knowledge & Skills:

- Previous experience in the pharmaceutical industry withthorough knowledge of Quality Systems, Quality Assurance, and Quality Controlincluding global GMP Quality Systems and regulatory requirements preferred

- Solves complex problems; takes a new perspective usingexisting solutions

- Works independently with minimal guidance

- Explains difficult issues and works to build alignmentaround a complex situation

- Accountable for a medium project with minimal resourcerequirements, risk and/or complexity

- Ability to work across boundaries; demonstratedinterpersonal, relationship building and leadership skills

- Communicates easily in English both verbally and inwriting

- Strong knowledge of External Manufacturing management,supply chain, and operations, preferably direct experience with managingexternal partners

PreferredExperience and Skills:

- Experience with manufacturing operations and/oranalytical expertise associated with biologics and/or vaccines. Asepticmanufacturing experience

- Experience with qualification of manufacturingfacilities/equipment (i.e. Process/Cleaning Validation, IQ/OQ/PQ)

- Competency in Analytical MethodValidation/Verification/Transfer and Analytical Standards

- Quality Risk Management (QRM) Experience

Qualifications& Education:

- Bachelor's or Master's degree in a Science, Engineering,or related area of study.

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