Find Operations lead Jobs in Balbriggan, D

Associate Director Validation
PCI Pharma Services —Stamullin, County Meath
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Process Shift Operator
Indaver —Drogheda, County Louth
- Full-time
- Maintenance
- Leaving certificate
- No degree
- Annual leave
- Employee assistance program
Quick apply
12d
Manager, Automation Engineering
PCI Pharma Services —Stamullin, County Meath
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Supervisor
Primeline Group —Ashbourne, County Meath
- Weekend availability
- ERP systems
- Analysis skills
- Supervising experience
Quick apply
Inventory Manager
Primeline Group —Ashbourne, County Meath
- Full-time
- Microsoft Excel
- Analysis skills
- Leadership
Quick apply
General Manager
Wingstop UK - Dublin DK —DUBLIN 11, County Dublin
- €41,350–€46,500 a year
- Part-time
- Management
- Leadership
- Restaurant experience
- Employee discount
Quick apply
12d
School Aged Childcare (SAC) Manager
The Hive Childcare —Donabate, County Dublin
- From €20 an hour
- Full-time
- Childcare
- Management
- Supervising experience
- Employee assistance program
- Employee discount
Quick apply
7d
Cluster Site Supervisor- Data Center
BidvestNoonan —Swords, County Dublin
- €17.91 an hour
- Full-time
- Microsoft Office
- Analysis skills
- Supervising experience
Quick apply
Emergency Department Operations Lead
Beaumont Hospital —Dublin, County Dublin
- €61,219–€74,251 a year
- Overtime
- Management
- Analysis skills
- IT
4d
Senior Manager, Global Mobility Technical
Coca-Cola —Drogheda, County Meath
- Full-time
- Analysis skills
- Bachelor's degree
- Accounting
1d
Part time NIGHT Staff Nurse
Marian House —DUBLIN 11, County Dublin
- €25 an hour
- Full-time
- English
- Bachelor's degree
- Patient care
- Annual leave
- Life insurance
Quick apply
12d
Crop Protection Manager
Keelings —Saint Margaret's, County Dublin
- Full-time
- Microsoft Excel
- English
- Leadership
Quick apply
Quality & Continuous Improvement Lead - UPMC Sports Surgery Clinic, Dublin
UPMC —Santry, County Dublin
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Air Logistics Healthcare Branch Manager
Kuehne+Nagel —Swords, County Dublin
- Continuous improvement
- Budgeting
- Leadership
HR & Payroll Generalist
Trane Technologies —Swords, County Dublin
- Full-time
- Bachelor's degree
- Human resources
- Organisational skills
Agronomy Manager
Keelings —Saint Margaret's, County Dublin
- Full-time
- English
- Leadership
- Communication skills
Quick apply
Deputy General Manager
Marine Hotel Sutton —Sutton, County Dublin
- From €48,000 a year
- Weekend availability
- Employee discount
Quick apply
4d
Senior Site Reliability & Maintenance Manager
Mondelēz International —Coolock, County Dublin
- Full-time
- Engineering
- Maintenance
- Bachelor's degree
Property and Asset Manager
Fold Housing Association —Santry, County Dublin
- €66,722–€77,668 a year
- On call
- Microsoft Excel
- Maintenance
- Contracts
5d
Farms Business Unit Director - Ireland
Keelings —Saint Margaret's, County Dublin
- Full-time
- Master's degree
- Bachelor's degree
- Continuous improvement
Quick apply
12d

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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

operations lead jobs in balbriggan, d

Associate Director Validation

Process Shift Operator

Manager, Automation Engineering

Supervisor

Inventory Manager

General Manager

School Aged Childcare (SAC) Manager

Cluster Site Supervisor- Data Center

Emergency Department Operations Lead

Senior Manager, Global Mobility Technical

Part time NIGHT Staff Nurse

Crop Protection Manager

Quality & Continuous Improvement Lead - UPMC Sports Surgery Clinic, Dublin

Air Logistics Healthcare Branch Manager

HR & Payroll Generalist

Agronomy Manager

Deputy General Manager

Senior Site Reliability & Maintenance Manager

Property and Asset Manager

Farms Business Unit Director - Ireland

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