[Apply in 3 Minutes] Quality Specialist – Quality Systems

Tipperary, Ireland | Posted on 01/06/2025

- Industry: Pharma/Biotech/Clinical Research
- Work Experience: 4-5 years
- Country: Ireland

Job Description

About PSC Biotech
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points, which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/Biotech Industry. We offer a permanent contract of employment giving exposure to working in top Pharmaceutical client sites in a diverse cultural work setting.

Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech; we provide unparalleled empowering career development through Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high-performing teams that can exceed our client’s expectations regarding quality of all scalable and business unit deliverables, staying under budget, and ensuring timelines for our deliverables are being met.

Overview:
The Quality Specialist – Quality Systems supports the Quality Systems activities in both the Drug Substance and Drug Product. The Quality Specialist participates as a member of the Quality Systems Team.

Requirements

Role Functions:

- The incumbent ensures timely and effective completion of the Quality Systems core functions in accordance with schedules and policies, procedures, and guidelines.
- Complete sub-system ownership responsibilities as per the site System Ownership list.

Quality SME for Process, Cleaning, Water, Equipment:

- Provide leadership, through knowledge and skill regarding the validation standards required for a Drug Substance and Drug Product (SDI & OSD) pharmaceutical facility.
- Participate in and support the site PVC (Process Validation Committee), WVC (Water Validation Committee), CVG (Cleaning Validation Group), and Equipment Qualification Validation Committee (EQVC).
- Approve all validation documentation and ensure compliance with policies, procedures, and guidelines. Ensure that validation status is maintained following changes/modifications.
- Support the implementation of site or capital projects by defining validation requirements and providing technical assistance and support as a member of the project teams.
- Develop Validation Summary Reports and assist in developing overall Quality plans for major projects.
- Work with other areas in the industry to predict future trends in validation and determine best practices.
- SAP Quality Process Steward.

Quality SME for Change Control:

- Principal Quality contact for all site change requests (with impact on processing) – Provide Quality and change analyst review for all change requests through all stages of the change control process ensuring compliance with site policies, procedures, and guidelines.
- Principal Quality contact for all Quality assessment of material control strategies associated with change requests for processing and analytical changes.
- Laboratory QA oversight.
- Support and approve the systems supporting laboratory functions, instrumentation, and GLIMS. Provide Quality oversight and approval for laboratory incidents/investigations and documentation.
- Stability oversight: Review and approval of stability reports (Intermediate and API stability data and reports are reviewed for accuracy and to support OOS and investigations as appropriate).
- Microbiology Point of Contact: Knowledge of microbial requirements in the pharmaceutical industry, to liaise with site Microbiologist for all microbial issues (e.g., water, utilities, environment, excipient, or product) as necessary.

Quality Agreement System Management:

- Manage the site inventory of Quality Agreements to ensure Quality Agreements are raised for all required relationships. Interact and communicate with SD&PM, relevant stakeholders, and external parties to ensure appropriate Quality Agreements are current, approved, on file, and retrievable.

Annual Review System Management:

- Manage the system ensuring that Annual Reviews (AR/APR/PQR) for products and systems including automation are completed to meet the Annual Review schedule.

Creation, review, and approval of Site Quality documentation including:

- Site Master File, Validation Master Plan, policies, or procedures.
- Quality Oversight of site application User Access Reviews.
- Approval of all designated user access reviews, ensuring compliance with site policies and procedures.

Quality Council:

- Manage the annual quality council schedule.
- Manage the monthly quality council agenda, minutes, and action follow-up.

Supplier Change Evaluations - Quality Role:

- Review and approve Supplier Change Evaluation documentation.
- Generate quality/technical agreements with suppliers as appropriate.

Supplier and Customer complaints:

- Participate in the investigation and review of any internal/external customer complaints in accordance with agreed lead-times.
- Participate in the investigation and review of any supplier complaints in accordance with agreed lead-times.

Filing & Licence maintenance and Regulatory Requests follow-ups:

- Review and ongoing maintenance of site licences.
- Provide site documentation to support product filings in accordance with CMC requests.

QA Regulatory Data:

- Review and verify documentation that may be used for submission to Pharm - CMC or other requester(s) for regulatory submissions/filings.
- Assure the accuracy and integrity of all data and information through a timely review program.

Returned Goods:

- Manage the segregation and disposition of all returned goods.
- Support the internal GMP walk-down and scheduled audits program.
- Support hosting of site Regulatory Inspections.

Special Features:

- The incumbent operates as part of a self-directed team in carrying out day-to-day functions and assigning priorities.
- The incumbent monitors appropriate performance metrics to ensure that the CoE delivers on all responsibilities in line with business needs.
- On assignment, the incumbent participates in departmental initiatives on improved compliance and quality systems and participates in cross-functional interdepartmental teams.
- The incumbent must be assertive with excellent communication skills, who can develop cross-functional relationships and network outside the plant.
- The incumbent promotes GMP awareness at the site.
- Validation principles and guidelines.
- Understands key business drivers and uses this knowledge to make decisions and prioritize.
- System Development Life Cycle.

Business:

- The Specialist must demonstrate the core values and behaviours.
- The Specialist must possess a high standard of knowledge and skills in the following areas:
- Computer Applications: Word, Excel, Access, eLogs, File, and Email Management.
- Meetings Management.
- Technical report writing.
- Time management.
- Analytical Problem-solving skills applied to issue identification and resolution.
- Responds to non-standard requests.
- Supports cross-functional investigations.
- Timely decision making.
- Inclusion behaviours.

Leadership:

- Strong Communication skills both written and oral including persuading others.
- Pro-active approach.
- Planning and scheduling.
- Brainstorming/Ideas generation - tools and techniques.
- Interpersonal Skills.
- Interpersonal Team membership and leading Skills (e.g., Listening, integrating diverse perspectives, adds value to the achievement of team goals).

Qualifications:

- Minimum of Degree or post-graduate qualification in Science, Pharmacy or Engineering field.

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