Qualification & Validation Specialist Job at S.T.B. ValiTech S.r.l. (Milano)

Commissioning & Qualification Specialist

Airswift is looking for a Commissioning & Qualification Specialist to work with ...

Location

United States , Birmingham

Salary:

Not provided

Airswift Sweden

Expiration Date

Until further notice

Requirements

Bachelor’s degree preferably in Engineering or Science discipline
3 to 5 experience in validation / qualification of aseptic pharmaceutical processes and / or equipment
Strong understanding of Regulatory Guidance Framework FDA/EU, Industry Best Practices and GMPs
Comprehensive knowledge of pharmaceutical manufacturing equipment and processes

Job Responsibility

Develop URS, SIC and SRA for new and existing aseptic facilities and equipment
Develop and execute Commissioning (COM) and Installation qualification (IQ) protocols
Perform operational qualification (OQ) and performance qualification (PQ) activities
Ensure all documentation is compliant with regulatory requirements and internal quality standards
Conduct risk assessments and implement mitigation strategies for aseptic processes
Proficient in the use of word processing, spreadsheet and presentation software programs
Proficient in use if Kaye Validator AVS and Val Probe Systems
Knowledge on following equipment qualifications: Homogenizers, Pump Skids, SIP & CIP Skids, Temperature control units, Tanks, Requalification of CTU’s
Develop and implement validation plans for computerized systems
Conduct risk assessments to identify potential issues related to system functionality and data integrity

Adhd Specialist Independent Prescriber

The ADHD Specialist Independent Prescriber plays a critical role in delivering h...

Location

United Kingdom

Salary:

61000.00 GBP / Year

Psychiatry UK

Expiration Date

Until further notice

Requirements

Registered Nurses: First-level registered Mental Health nurse (RMN) or First-level registered nurse (Adult Nurse/Children’s Nurse/Learning Disabilities Nurse) (with one year post qualification Secondary Mental Health service experience or further Mental Health qualification)
Must have Independent & Supplementary Non-Medical Prescribing (V300) qualification with 1-year post-prescribing qualification experience
1-year post prescribing qualification experience in Specialist ADHD Service. (Specialist ADHD experience can include working within private and/or NHS Secondary mental health practice) or equivalent
ADHD experience must include managing ADHD patients with prescribing responsibilities, including medication initiation, titration, review, and long-term management
Pharmacists: Registered Pharmacist with Non-Medical Prescribing Qualification
One year post qualification secondary mental health service experience or further training or One year post prescribing qualification experience in Specialist ADHD service. (Specialist ADHD experience can include working within private and/or NHS practice) or equivalent
ADHD experience must include managing ADHD patients with prescribing responsibilities, including medication initiation, titration, review, and long-term management
Sound clinical experience in the initiation, titration, and management of ADHD in adults
Strong patient-centred approach, showing empathy, professionalism, and the ability to build rapport with patients and colleagues
Excellent communication and interpersonal skills

Job Responsibility

Provide safe, effective, and evidence-based prescribing for adult ADHD patients in line with NICE guidelines, Psychiatry UK clinical policies, and the Royal Pharmaceutical Society (RPS) Prescribing Framework
Manage a defined caseload of patients during the titration and ongoing treatment phases, ensuring timely review of treatment effectiveness, side effects, and adherence
Communicate with patients through Psychiatry UK’s secure portal, offering clear, supportive, and clinically appropriate responses to medication-related queries
Complete End of Titration Reviews (EOTRs) and conduct annual medication reviews in a timely and thorough manner, ensuring continuity and quality of care
Exercise independent or supplementary prescribing rights within scope of practice, recognising limitations and seeking clinical advice when necessary
Collaborate closely with Consultant Psychiatrists and the wider ADHD service team to ensure coordinated, patient-centred care
Undertake regular risk assessments and review safeguarding concerns, escalating appropriately in line with organisational policy
Maintain accurate, detailed, and confidential clinical records using Psychiatry UK’s digital systems in accordance with professional and legal standards
Participate in audits, quality improvement activities, and the review of prescribing practices to support clinical governance and service development
Engage in regular clinical supervision and team learning to maintain high standards of clinical decision-making

What we offer

Health Cash Plan and Wellbeing Hub subscription
Employee Assistance Programme
Annual Volunteering Day
Enhanced Sickness and Family Leave pay
Length of Service Bonus
Work from Home allowance
Pension options
£1,000 per annum - working from home allowance
£5,000 - joining bonus

Regulatory Affairs Specialist

Hemostasis, LLC designs, develops, manufactures, and markets advanced hemostat, ...

Location

United States , Saint Paul

Salary:

Not provided

Hemostasis Corp

Expiration Date

Until further notice

Requirements

Master’s degree in Regulatory Affairs and Services
Excellent written and oral communication skills
Demonstrate proactive and strategic thinking and be able to handle change and ambiguity

Job Responsibility

Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, and clarification/follow-up of submissions under review
Provide technical review of data or reports that will be incorporated into regulatory submissions
Analyze validation test data to determine whether systems or processes have met validation criteria
Study product characteristics or customer requirements and confer with management to determine validation objectives and standards
Identify deviations from established product or process standards and provide recommendations for resolving deviations
Develop validation master plans, process flow diagrams, test cases, and standard operating procedures
Create, populate and maintain the database for tracking validation activities, test results and validation systems
Prepare, maintain, and review validation and compliance documentation such as engineering change notices, schematics, and technical files to obtain and sustain product approval
Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements
Prepare additional information or responses as requested by regulatory agencies

What we offer

401K
Dental
Life
Medical
Disability
Competitive salary and benefits package including health, life, retirement and related benefits

Fulltime

GMP QC Specialist, CMC

Reporting to the Director, QA Operations, the GMP QC Specialist, CMC, will be re...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in scientific discipline
Advanced degree preferred
Minimum of 5 years’ hands-on experience in biopharmaceutical technical operations, QC operations and/or quality operations
Minimum of 2 years’ hands-on experience in GMP laboratory environment, with specific familiarity with cell and gene therapy release assay development, performance, and qualification
Specific experience performing or reviewing microbiological assays, including compendial methods (sterility, endotoxin, mycoplasma assays, APS, APV and Environmental Monitoring)
Experience interacting with external testing laboratories preferred
Working knowledge of GMP and ICH guidance and both US and international regulatory requirements
Highly organized, effective, and proactive communicator verbally and in writing. Able to work independently to appropriately prioritize work
Strong team orientation and passion for continuous self-development
Experience in industry or in a startup industrial setting is preferred

Job Responsibility

GMP Compliance: Ensure that all internal laboratory activities are maintained in accordance with internal data integrity practices and standards. Ensure that external laboratory activities comply with GMP regulations and guidelines. Stay current with regulatory requirements and industry standards related to GMP
Batch Review / Release: Perform full batch record review of all types of investigations
perform appropriate quality control review of all QC data generated by third parties
draft, review, and approve CoA (internal/external)
Investigations: Identify issues of non-compliance and work directly with the third party to resolve prior to batch release. Review and approve any out-of-specification investigations in a timely manner
Quality Control Procedures: Develop, implement, and maintain quality control procedures to monitor and assess internal laboratory processes, as well as the processes employed by external laboratories used to generate QC data. Conduct regular reviews to identify areas for improvement and initiate corrective action(s) as needed
Audits and Inspections: Assist in the planning and conducting of internal audits to assess compliance with data integrity standards and approved procedures (e.g. SOPs, test methods). Support audits of external laboratories as needed
Assay Qualification / Validation: Review and approve assay development, qualification and validation plans, data generated and reports. Provide primary QC support for all activities
Documentation Management: Oversee the creation, review, and approval of laboratory documentation, including SOPs, test methods, protocols, and reports. Ensure that the documentation is accurate, complete, and in compliance with GMP requirements. Ensure all Process Development (Analytical Development and Manufacturing Sciences & Technology) related documentation and data are reviewed and archived in a timely and accurate manner
Training and Education: Assist in providing training and guidance to Process Development personnel on GMP principles, procedures, and compliance requirements. Ensure that all team members are informed and adhere to quality control measures

What we offer

health and retirement
PTO
stock option plans

Independent Prescribing Pharmacist – ADHD Specialist

Join our client’s specialist ADHD service as a Prescribing Pharmacist and play a...

Location

United Kingdom

Salary:

50.00 - 63.00 GBP / Hour

Hunter Gatherer AHP

Expiration Date

Until further notice

Requirements

A valid GPhC registration as a Pharmacist
Completion of the Independent Prescribing qualification (mandatory)
Prior experience working in ADHD or mental health services
Confidence in remote prescribing and patient communication
Your own secure and up-to-date IT equipment suitable for remote work (laptop, webcam, secure internet)

Job Responsibility

Conduct clinical assessments and ADHD medication reviews
Prescribe and adjust ADHD medications in line with NICE guidance
Provide remote consultations to patients and families
Work closely with clinicians, nurses, and mental health teams to ensure safe and effective care
Maintain accurate documentation and ensure compliance with national prescribing standards

What we offer

Fast & simple AHP locum registration
A network of like-minded AHP professionals
Reliable, high-paying locum jobs with bi-weekly payroll
Specialist AHP recruitment consultants
Exclusive NHS & private sector job opportunities
CV marketing & business development support
Industry insights, networking events & discounted CPD

Fulltime

Manager Manufacturing, Single Use Systems & Validation

Act as the Manager for the Single Use Systems and Cleaning Validation Team in ou...

Location

United States , Holly Springs

Salary:

126376.00 - 159170.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma/GED and 12 years of biotechnology operations or validation experience
Associate’s degree and 10 years of biotechnology operations or validation experience
Bachelor’s degree and 5 years of biotechnology operations or validation experience
Master’s degree and 3 years of biotechnology operations or validation experience
Doctorate degree

Job Responsibility

Provide technical leadership and subject matter expertise for Single Use Systems and equipment cleaning validation activities in the manufacturing area
Oversee development, implementation, and maintenance of SOPs, training materials, and Quality Management System records related to Single Use Systems and equipment cleaning validation
Lead development and execution of the site’s Cleaning Validation Master Plan (CIP/SIP/COP for equipment and controlled temperature chambers), validation plans, equipment qualification protocols/reports, and cleaning validation strategies
Manage and mentor a team of specialists and engineers, including hiring, training, performance evaluations, and development
Coordinate troubleshooting and support during commissioning, qualification, start-up, and process performance qualification of the facility
Facilitate process, area, and equipment risk assessments to identify risks, failure modes, and mitigating actions
Ensure compliance with regulatory requirements, support regulatory submissions, audits, and inspections
Champion Lean Transformation and operational excellence initiatives, driving continuous improvement in the plant
Collaborate cross-functionally with Manufacturing, Engineering, Quality, Supply Chain, and Process Development to ensure alignment and readiness for new products, process changes, and advanced technologies
Develop and implement training plans and programs to ensure staff are prepared and compliant

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Fulltime

Quality Control Specialist

Lead analytical equipment qualification for new equipment and technology introdu...

Location

Singapore

Salary:

Not provided

Amaris Consulting

Expiration Date

Until further notice

Requirements

Experience in analytical equipment qualification, including computer system validation for analytical equipment
Knowledge of the operation of analytical equipment
Experience in QC testing
Knowledge of cGLP and cGMP
Knowledge of compendia and regulatory requirements
Academic background: University degree in a relevant science discipline with at least 2 years of relevant working experience, or diploma with at least 3 years of relevant working experience
Fluent English
You demonstrate strong project management and communication skills

Job Responsibility

Lead analytical equipment qualification for new equipment and technology introduction
Ensure timely implementation of projects with full compliance to corporate, regulatory, and external agency regulations
Collaborate closely with local and global stakeholders on new equipment and technology introduction and qualification
Write change controls, events/deviations, CAPAs, and GMP documents (e.g., SOPs, protocols, reports)

What we offer

Global Diversity: Be part of an international team of 110+ nationalities
Trust and Growth: 70% of our leaders starting at entry-level
Continuous Learning: internal Academy and over 250 training modules
Vibrant Culture: afterworks, networking events
Meaningful Impact: CSR initiatives, including the WeCare Together program

Fulltime

Senior Physician, Patient Safety

Join our dynamic Patient Safety team as a Senior Physician where you'll leverage...

Location

United States; Canada , Remote; Alberta

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experience in clinical medicine (general or specialist qualifications) which is expected to be kept up to date
Good knowledge of drug safety and the drug development process
Good knowledge/understanding of medical terminology
Relevant experience in pharmacovigilance/ Drug Safety/ Clinical Practice
3 - 5 years previous experience in pharmacovigilance and/or medical monitoring is required
US Board Certification/board eligibility or regional equivalent for Canada
Bachelor of Medicine, Bachelor of Surgery (MBBS) / Doctor of Medicine (MD)/ Medically qualified from an acknowledged Medical School
Completion of at least basic training in clinical medicine (residency, internship etc.)
Demonstrated success in technical proficiency and scientific creativity
Good presentation and verbal/written communication skills

Job Responsibility

Maintaining a good working knowledge of the Adverse event/Safety profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and global drug safety regulations and guidelines
Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
Performing medical review of cases not limited to (including complex and challenging cases requiring expert judgement)), clinical trial, and literature cases including combination products {drug-device}) according to client/Parexel Standard Operating Procedures (SOPs
as applicable) and liaising with the client, as require
Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality
Review appropriateness of medical content in narrative for medical coherence
Assessing seriousness, listedness / expectedness of reported events
Providing medical inputs to case processing team
Raising appropriate follow-up queries for relevant information from the reporter/HCP (Health Care Professional)
Review and verify appropriate selection of adverse events from source documents, assign appropriate Medical Dictionary for Regulatory Activities (MedDRA) code, review narrative

What we offer

Flexible approach to work that meets your personal needs
Work from home
Benefits vary by country
Investment in your professional and personal development

Qualification & Validation Specialist

S.T.B. ValiTech S.r.l.

Location:
Italy , Milano

Category:
Quality Control

Contract Type:
Not provided

Salary:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
December 12, 2025

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