Find Experience necessary Jobs in Collon, Lh

Associate Director Validation
PCI Pharma Services —Stamullin, County Meath
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Head of Corporate Development
ABP Food Group —Ardee, County Louth
- Full-time
- Leadership
- Communication skills
Quick apply
General Maintenance Person
Durnins Fruit and Veg —Navan, County Meath
- Part-time
- Maintenance
- No degree
- Communication skills
Commissioning Engineer
Glanua —Navan, County Meath
- Full-time
- Microsoft Word
- Microsoft Excel
- No degree
- Annual leave
- Employee assistance program
Quick apply
Mechanical Site Fitter (Navan)
Glanua —Navan, County Meath
- Full-time
- Communication skills
- Mechanical knowledge
- Annual leave
- Employee assistance program
Quick apply
Factory Manager
Unilin —Navan, County Meath
- Management
- Engineering
- Continuous improvement
3d
Welder/Fitter
TWP Engineering —Dromiskin, County Louth
- €45,000–€50,000 a year
- Full-time
- English
- Welding
- Hand tools
Quick apply
2d
Chef
Cathedral Restaurant —Dundalk, County Louth
- €17–€20 an hour
- Weekend availability
- Culinary experience
- Cooking
- No degree
- Employee discount
Quick apply
2d
Support Worker | Full Time, Part Time and Relief | Navan Bective
Praxis Care —Navan, County Meath
- €32,543.37–€45,163.08 a year
- Full-time
- Organisational skills
- Leadership
- Communication skills
- Annual leave
- Employee discount
Quick apply
3d
Business Development Manager- Ireland
SUPPLY TECHNOLOGIES —Dundalk, County Louth
- Analysis skills
- Leadership
- Communication skills
Quick apply
Quality Manager, Platin Works
Irish Cement Ltd. —Louth, County Louth
- Full-time
- Microsoft Office
- No degree
- IT
Quick apply
2d
CNC Programmer - Swiss Lathe
Gus Precision Engineering Services —Dundalk, County Louth
- €46,000–€55,000 a year
- Manufacturing
- Sick pay
Quick apply
3d
Assistant Resident Engineer
AtkinsRéalis —Dundalk, County Louth
- Weekend availability
- Hybrid work
- AutoCAD
- English
- Microsoft Office
Post Doctoral Fellow Level 1 Beef Systems Modeller
Teagasc —Grangegeeth Cross Roads, County Meath
- €45,520–€49,889 a year
- Full-time
- Doctoral degree
- Data analysis skills
- Research
9d
Resident Engineer
AtkinsRéalis —Dundalk, County Louth
- Weekend availability
- Hybrid work
- AutoCAD
- English
- Microsoft Office
Manager, Automation Engineering
PCI Pharma Services —Stamullin, County Meath
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Mechanical Site Fitter
Glanua —Navan, County Meath
- Full-time
- Communication skills
- Mechanical knowledge
- Annual leave
- Employee assistance program
Quick apply
10d
Design Engineer
Glanua —Navan, County Meath
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
- Annual leave
- Employee assistance program
Quick apply

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Associate Director Validation

PCI Pharma Services -
Stamullin, County Meath

Apply Now

Job details

Full-time

Qualifications

Microsoft Powerpoint
Microsoft Word
Microsoft Excel
Microsoft Office
Bachelor's degree
Business requirements
Communication skills

Full job description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

This role will be a key member of the Site Quality Leadership Team that influences the wider organisation by demonstrating leadership through actions, accountability coaching and development of the Validation Team, Quality, and function departments validation work closely with.

The role of the Associate Director Validation is to lead the implementation and execution tasks relating to Process, Facility, Laboratory, Computer System Validation (CSV), Cleaning and Equipment Development at PCI Ireland Pharma Services sites.

Main responsibilities:

The Associate Director Validation is responsible for PCI Ireland validation design, strategy, compliance, and overall adherence to VMP.
The Associate Director Validation is responsible for communicating the strategy to site leadership and working closely with all functional departments to ensure the VMP is understood and ultimately adhered to.
Ensuring all validation activities on site relating to Facility, Laboratory Equipment, CSV, Processes (packaging and cleaning), and Data Integrity meet the expectations of clients but more specifically meet regulatory requirements (HPRA/ FDA).
Define Validation KPI’s, and validation schedule. Utilise SQDC to manage operations for validation and provide weekly summary of SQDC outputs to Quality Director.
Manage the validation team. Train, develop, coach the team on the validation system, documenting, and execution. Manage HR related activities. Complete Quantum for Team and yourself in a timely manner ensuring 1:1 conversation happen on time and team is aware for expectations.
The Associate Director of Validation is a key member of the site leadership team. In that capacity the incumbent must flag concerns with site validation should any be found, work with other departments (Engineering, Production, NPI, QC and others) to ensure the validation needs are understood. Validation depart must utilise risk methodology, be pragmatic, solution orientated with overall focus on validation compliance across the sites.
Be a member of Corporate Centre of Excellence (COE) ensuring best practices are shared and implemented. Work closely with sister sites to ensure One PCI experience is demonstrated to our customers.
Ensure periodic review and annual validation plan is in place and adhered to. Any slippages should be reported through SQDC model. Introduce Continuous Process Verification in line with best practice.
Generate validation template protocols for new and existing computer systems, facilities, equipment and processes and review/approve all reports. Protocols should be designed around maximising equipment CSV capability ALCOA+ principles. Ensure all protocols have a clear author and approval process, and its clearly understood within the protocol who is responsible for which activities and it is very clear who executed within the protocol.
Generate and maintain documentation for cleaning validation performed at PCI sites in Ireland in line with current best industry practice.
Execute validation activities, with minimal supervision, in conjunction with Technical, Production and Engineering functions.
Manage tooling validations and associated documentation.
Ensure the strict implementation of validation procedures plus the timely and accurate completion of all validation documentation.
Support complaint investigations, deviation investigations and change controls as required.
To undertake such tasks and to manage specific or ad hoc projects as and when required to meet business needs and within the scope of the job-holder’s capabilities.
Identify and support opportunities for improving processes and or procedures.
Be a Leader, continue to drive good practice (cultural and technical) across the site, and continually improve the validation system.

Essential Requirements:

Bachelor’s or associate degree in Validation / Technical Engineering or Science based subject
+10 years' experience working in Validation across Qualifications and Process Validation
Communication: Excellent communication and presentations skills, both written and oral – ability to present risk-based project validation strategy in a clear and concise manner to the Business Unit Planners, Customers and where required, to Senior Management
QMS system experience necessary
Proven track record of showing how results were delivered through project management
Capability to follow clear goals, communicate clearly and ensure progress to completion meeting predefined targets.
Ability to manage multiple tasks and set priorities.
Problem Solving and Troubleshooting skills. The successful candidate should display a dynamic and proactive approach to manage problems.
Self-motivated with a results driven approach.
Adaptable and ability to work collaboratively.
Proficient in Microsoft Office products (incl. Excel, PowerPoint, Word, etc.)
Some travel required for business requirements
Customer facing experience
Adaptability: Able to work in a fast, dynamic, environment whilst being able to adjust readily to meet unexpected constraints
Passion for Results: Drive, high energy, maturity, and ability to work under pressure and deliver results; get things done (an action-oriented approach); overcome obstacles
Decision Making: Identify and understand issues, problems and opportunities whilst providing
Strong insight into Pharma/Medical Device guidelines relating to regulatory and quality requirements

#LI-MS1

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Apply Now

Refine Your Search

experience necessary jobs in collon, lh

Associate Director Validation

Head of Corporate Development

General Maintenance Person

Commissioning Engineer

Mechanical Site Fitter (Navan)

Factory Manager

Welder/Fitter

Chef

Support Worker | Full Time, Part Time and Relief | Navan Bective

Business Development Manager- Ireland

Quality Manager, Platin Works

CNC Programmer - Swiss Lathe

Assistant Resident Engineer

Post Doctoral Fellow Level 1 Beef Systems Modeller

Resident Engineer

Manager, Automation Engineering

Mechanical Site Fitter

Design Engineer

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