Project / GMP Specialist – Manager Job at The Emerald Group Ltd, Search and Selection (Nationwide)

Project / GMP Specialist Senior Manager

This role will involve leading large-scale, data-intensive, and technically chal...

Location

United Kingdom

Salary:

Not provided

The Emerald Group Ltd, Search and Selection

Expiration Date

Until further notice

Requirements

Strong actuarial or pensions project experience, particularly in GMP Equalisation
Benefit Rectification
Insurance Readiness or similar large-scale projects
Proven experience leading large & complex projects
Ability to analyse and resolve complex technical issues
Experience working across multiple clients and project environments

Job Responsibility

Lead the end-to-end delivery of large and complex actuarial and data projects
Provide solutions for complex and non-standard cases, guiding the team through technical challenges
Supporting the development of solutions for niche and complex actuarial issues

Fulltime

Engineering Project Specialist

The Projects Engineering Specialist has the overall responsibility for deliverin...

Location

Philippines , General Trias, Cavite

Salary:

Not provided

Unilever

Expiration Date

Until further notice

Requirements

Minimum Technical Course or 4-year Engineering Course
Project Management Skills
Excellent knowledge of Unilever and SHE Standards
Good knowledge of Manufacturing and Process Safety
Influencing, Good Observation, and Auditing Skills
Engineering course preferably Mechanical, Electrical, Chemical, and Industrial
Experience in Supply Chain operations
Manufacturing and/or Engineering experience
Proven track record of analytical thinking and project management
Open to Fresh Grads and With Work Experience

Job Responsibility

Ensure compliance to Safety and Occupational Health procedures
Ensure compliance to environmental policy
Ensures compliance to GMP and HACCP
Participates in QBO program
Follow prescribed work procedures and company safety rules and regulations
Compliance to company COBP, CR&R
Compliance to the GMP and GHK rules of the plant
Deliver targets/KPIs as aligned with his/her Line Manager
Participates in Focused Improvement activities
Executes agreed Focused Improvement actions

Fulltime

GMP Engineering Compliance Specialist

We are seeking an Engineering Compliance Specialist to support engineering syste...

Location

Singapore , Singapore

Salary:

Not provided

Amaris Consulting

Expiration Date

Until further notice

Requirements

Bachelor's degree in Engineering, Life Sciences, or related field
Experience in pharmaceutical, biotech, life sciences, or GMP-regulated manufacturing environments
Hands-on or review experience in engineering system checks, asset review, maintenance risk assessments, or calibration activities
Good understanding of GMP documentation practices and engineering compliance requirements
Ability to review engineering records, maintenance records, calibration documentation, and related technical documents
Strong attention to detail, structured working approach, and ability to coordinate effectively with cross-functional stakeholders
Experience in pharmaceutical manufacturing, biologics, sterile manufacturing, or API production is an advantage
Exposure to validation, qualification, CQV, or GMP project support activities is preferred
Familiarity with equipment lifecycle management, preventive maintenance, calibration programs, or asset management systems is an advantage
Experience supporting audit readiness or GMP documentation remediation activities is preferred

Job Responsibility

Support engineering system checks within a GMP manufacturing environment
Review asset records and equipment status to ensure proper documentation and compliance
Conduct or support maintenance risk assessments for manufacturing and engineering systems
Review calibration status, calibration records, and related documentation
Assess whether engineering activities may impact GMP compliance, product quality, or equipment readiness
Collaborate closely with Engineering, Quality, Maintenance, Validation, and Manufacturing teams
Review and support preparation of GMP documentation, reports, checklists, and compliance records
Identify documentation gaps and support follow-up actions or remediation activities
Ensure all work is performed in line with GMP, GDP, and site quality requirements

What we offer

An international community, bringing together 110+ different nationalities
An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities
A robust training system with our internal Academy and 250+ available modules
A vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.)
At Mantu, sustainability is part of everything we do. You’ll have the opportunity to turn your ideas into action and make a tangible impact
Through our WeCare Together program, you’ll be empowered to design and lead projects that create real social or environmental impact, with the company’s full support

Fulltime

New

Accounting Specialist

Location

United States , Charlotte

Salary:

Not provided

Beacon Hill

Expiration Date

Until further notice

Requirements

1-3+ years of accounting experience, ideally within a project-based or construction environment
3-5 years of working knowledge of AIA billing processes
Familiarity with GMP and cost-plus billing structures preferred
Strong attention to detail, accuracy, and organizational skills
Effective communication skills (written and verbal)
Ability to manage multiple priorities, meet deadlines, and work both independently and collaboratively

Job Responsibility

Prepare and submit monthly AIA billing packages in accordance with contract requirements
Review project contracts to ensure accurate billing and compliance with terms
Maintain detailed job billing records and supporting documentation
Monitor and manage accounts receivable aging
Process subcontractor pay applications and vendor invoices, ensuring proper documentation and approvals
Assist with tracking job costs for both billing and expense purposes
Address payment inquiries and resolve discrepancies
Maintain organized AP records and documentation
Support month-end and year-end close processes
Assist with job cost tracking and reporting as needed

Fulltime

New

Specialist Quality Assurance

Responsible for providing oversight and leadership for quality systems execution...

Location

Singapore , Singapore

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree OR Master's degree and 2 years of directly related experience OR Bachelor's degree and 4 years of directly related experience OR Diploma and 8 years of directly related experience
8 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical / biologics industry with progressively increasing responsibility and demonstrated experience in project management, quality assurance, and quality systems.
Direct experience with bulk manufacturing of biopharmaceuticals/API preferred.
Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff.
Experience with regulatory audits and inspections
Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality.

Job Responsibility

Provide Quality oversight to plant operations, ensuring appropriate application and execution of GMP compliance requirements and Amgen Quality Management System in plant operations through phases of commissioning, process qualification, regulatory approval and market supply
Support routine GMP documentation review activities (e.g. electronic batch records, SOPs, logbooks, work orders, batch production reports and validation protocols etc.) and ensure key performance indicator met targeted metrics
Co-lead and support the deployment of Amgen quality systems, including management review, validation, change control and CAPA and ensure that the systems are managed in compliance with cGMP expectations
Participate in complex root cause investigations for deviations
Review and approve deviation investigations, change controls, and other quality records (with focus on highly complex records)
Provides Quality Assurance support in New Product Introduction (NPI) team
Coach site Quality Assurance professionals on resolution of complex problems
Participate in regulatory inspections, and interact directly with regulatory inspectors
Supporting other Quality Assurance initiatives/activities such as continuous improvement projects, supplier quality, stability program, product quality review, customer complaint investigation.

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Specialist, Quality Complaint Investigation

This is where you make a difference in our patients’ safety. As a member of the ...

Location

Malta , San Ġwann tal-Għargħar, San Ġwann

Salary:

27200.00 EUR / Year

Baxter

Expiration Date

Until further notice

Requirements

Medical Device Experience with knowledge of 21CFR820 preferred
Investigational research skills
Experience with any statistical software packages (Minitab a plus)
Desired experience in the medical device industry in the development and deployment of Quality Systems, and process controls, and continuous improvement methods
Knowledge and working application of FDA cGMP
ANSI/ISO/ASQC requirements
CMDAS (optional)
Knowledge and working application of reading and understanding blueprints and technical drawings
Demonstrated strong analytical problem solving (Root Cause Investigations
Display a solid technical understanding of engineering principles and procedures (e.g. CAD and its application or scheduling a series of technical tasks utilizing software-based tools)

Job Responsibility

Investigation, review, and completion of all Quality Engineering complaint issue analysis tasks utilizing various quality system inputs
Review individual complaints and associated service data to determine risk level and complete investigation into the as determined problem code and cause codes for each complaint
Analyze data from various quality inputs (including but not limited to: Field Corrective Action (FCA), Complaints, FDA Medical Device Reports (MDR), etc.) to determine trends and systemic issues
Prepare and issue reports based on information analysis
Review existing investigation reports and identify gaps for GMP compliance
Develop strategies and plans to close the gaps in an efficient and technical manner
Develop and communicate expectations for quality performance, continuous improvement and process controls for marketed products
Monitor and drive corrective action and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions
Conduct or lead corrective and preventive actions in manufacturing using formal problem-solving tools and documentation
Support CAPA and maintenance activities for existing product lines

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
competitive benefits
discretionary bonuses
long-term incentive

Fulltime

BP Resin Sales Specialist

The Resin Sales Specialist is responsible for driving chromatography resin sales...

Location

India , Pune

Salary:

Not provided

Danaher Corporation

Expiration Date

Until further notice

Requirements

Master's degree preferably a Ph.D. holder in Biological Sciences with strong technical expertise in chromatography resins and 6–8 years of hands-on experience in the Downstream Processing division of the biopharmaceutical industry

Job Responsibility

Drive Design-In and Spec-Win activities for our chromatography resins by identifying new opportunities and closing deals
Plan and conduct customer meetings, and proactively identify and monitor their molecule pipelines to secure Design-In wins for our resins portfolio
Achieve annual and quarterly revenue targets through precise monthly and quarterly forecasting
Strategically plan mid- to long-term activities aligned with customer projects
Partner with Account Managers and Regional Marketing to organize impactful seminars, user days, product trainings, and new product introductions

Fulltime

Senior Consultant/Serialization Specialist

We are looking to strengthen our team in Denmark with a Senior Consultant / Seri...

Location

Denmark , Region Hovedstaden

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

5+ years of experience within IT compliance, serialization, CSV, or similar roles in the Life Sciences industry
Hands-on experience with serialization systems (e.g., Level 3/4 solutions, reporting systems, integration layers)
Strong knowledge of Computer Systems Validation (CSV) and/or Computer Software Assurance (CSA)
Solid understanding of relevant regulations such as: EU GMP Annex 11, FDA 21 CFR Part 11, GAMP5, Serialization regulations (EU FMD, US DSCSA)
Experience working with regulated IT systems and compliance frameworks
A strong consultancy mindset with excellent communication and stakeholder management skills
Ability to translate complex regulatory requirements into practical, business-oriented solutions
Experience working across IT, Quality, and Business domains
Ability to manage multiple tasks and projects while maintaining high quality
A proactive, collaborative, and solution-oriented approach

Job Responsibility

Acting as SME within Serialization, supporting implementation, rollout, and optimization of serialization solutions
Leading and supporting Computer Systems Validation (CSV) activities for serialization and related systems
Defining and implementing compliance strategies aligned with global regulatory requirements
Supporting IT/QA readiness assessments and developing validation approaches
Advising clients on serialization regulations (e.g., EU FMD, US DSCSA) and industry best practices
Driving vendor selection, evaluation, and oversight for serialization platforms
Supporting integration of serialization systems with ERP, MES, and other enterprise systems
Acting as a trusted advisor on compliance, quality, and governance within serialization programs
Facilitating workshops with business, IT, and quality stakeholders
Supporting audits and inspections related to serialization and validated systems

Fulltime

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Project / GMP Specialist – Manager

Job Description

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