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

Senior Validation Specialist

The role of the Senior Validation Specialist is to implement and execute tasks r...

Location

Ireland , Stamullen, Co. Meath

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Min 3 years' Quality experience
Min 2 years' Validation experience
Equipment Qualification (IQ, OQ, PQ) – Hands on experience in protocol generations, execution, completion
Process Validation (PV) experience
New Product Introduction (NPI) - Generation, execution and close out of validation projects
Communication Customer/Internal stake holders/Suppliers
Experience with deviation, CAPA processes
Flexible and able to manage multiple priorities simultaneously
Periodic reviews

Job Responsibility

Support the validation effort for all Strategic Projects on site
Ensure all validation activities on site relating to Facility, Equipment and Processes meet the expectations of clients but more specifically meet regulatory requirements (HPRA/ FDA)
Prepare, review and or approval of qualification and/or validation documentation (VMPs, specifications, protocols, reports etc.) in relation to instrument, equipment, facilities (including cold stores), utilities, automated systems, manufacturing processes and cleaning processes including FAT, SAT, IQ, OQ, PQ phases in conjunction with program Quality representation
Drive solutions, in conjunction with the appropriate department, to ensure customer related validation problems are communicated and corrective actions are in place and closed in a timely manner
Thorough investigation of Quality and Validation issues using Root Cause Analysis methodology and implementation of robust corrective and preventative actions to prevent recurrence
Support change controls as required
Execute validation activities, with minimal supervision, in conjunction with Technical, Production and Engineering functions
Ensure the strict implementation of validation procedures plus the timely and accurate completion of all validation documentation
Supports the coordination & scheduling of packaging validation activities in alignment with planning & packaging functions
Perform Periodic reviews, revalidations, and continued process verifications on a scheduled basis

Fulltime

Cqv Engineer

The CQV Engineer (Commissioning, Qualification, and Validation) will primarily b...

Location

United Kingdom , Keele

Salary:

Not provided

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Level 6 within a science regulated industry or relevant experience
Minimum 3 years Validation experience within Pharmaceutical/Medical Devices, including cleaning, analytical methods, lab equipment, and computer system validation and re-qualification
Creation of validation protocols and reports
Knowledge of Quality Management Systems
Comprehensive knowledge and experience with the following industry regulations and guidance: FDA 21 CFR Part 820 (Quality System Regulation for Medical Devices), ISO 13485:2016 (Medical devices - Quality management systems), ALCOA+ principles for Data Integrity (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available), ICH Q9 (Quality Risk Management) and its application to validation/qualification
Excellent communication skills
Ability to meet deadlines
Attention to detail
Demonstrate positive and enthusiastic attitude

Job Responsibility

Validation Activities: Organise and perform validation activities to provide an effective validation service
Compliance Documentation: Ensure all required documentation for a validation exercise, including validation protocols and summary reports, are created and maintained
SOP and Documentation Support: Provide input and technical expertise for the creation and revision of relevant Standard Operating Procedures (SOPs) and other quality \ Validation documentation
Project Alignment: Plan validation activities to ensure customer and business needs are met in alignment with the overall project plans, objectives and schedules
Compliance Assurance: Ensure design projects relating to processes, facilities, equipment, and Computer System Validation are in compliance with regulatory and company requirements
Expert Advice: Provide validation support and advice to operations and other areas of the business as required to ensure that all operations are carried out in compliance with regulatory and company requirements
Specialist Knowledge: Provide specialist knowledge on validation of
process, facility, equipment and application of computer systems used within production and service
Continuous Improvement: Support a continuous improvement culture within the business

What we offer

Company events
Company pension
Employee discount
Free or subsidised travel
Free On-site parking

Fulltime

Doctor / Specialist

MantraCare is hiring qualified Doctors and Specialists to provide structured tel...

Location

Malaysia

Salary:

Not provided

MantraCare

Expiration Date

Until further notice

Requirements

MBBS / MD or equivalent recognised medical qualification
Valid registration with the Malaysian Medical Council (MMC)
Specialist certification in your respective field (for specialist roles)
Minimum 2 years of clinical experience preferred
Experience in teleconsultation is an advantage
Strong diagnostic and communication skills
Reliable internet connection and private WFH setup

Job Responsibility

Conduct online medical consultations in your specialty area
Diagnose and manage patient cases virtually
Review medical history and recommend appropriate investigations
Provide treatment plans and prescribe medications as per guidelines
Offer follow-up consultations and monitor progress
Maintain secure and confidential digital medical records
Follow Malaysian healthcare regulations and ethical standards
Collaborate with multidisciplinary teams when required

What we offer

100% Remote Doctor Job in Malaysia
Flexible working hours
Access to a growing national patient base
No clinic rent or administrative overhead
Secure telemedicine platform
Structured documentation workflow
Transparent and competitive consultation-based compensation
Opportunity to expand your professional reach across Malaysia

Doctor / Specialist

MantraCare is hiring qualified Doctors and Specialists to provide structured tel...

Location

Singapore

Salary:

Not provided

MantraCare

Expiration Date

Until further notice

Requirements

MBBS / MD or equivalent recognised medical qualification
Valid registration with the Singapore Medical Council (MMC)
Specialist certification in your respective field (for specialist roles)
Minimum 2 years of clinical experience preferred
Experience in teleconsultation is an advantage
Strong diagnostic and communication skills
Reliable internet connection and private WFH setup

Job Responsibility

Conduct online medical consultations in your specialty area
Diagnose and manage patient cases virtually
Review medical history and recommend appropriate investigations
Provide treatment plans and prescribe medications as per guidelines
Offer follow-up consultations and monitor progress
Maintain secure and confidential digital medical records
Follow Singapore healthcare regulations and ethical standards
Collaborate with multidisciplinary teams when required

What we offer

100% Remote Doctor Job in Singapore
Flexible working hours
Access to a growing national patient base
No clinic rent or administrative overhead
Secure telemedicine platform
Structured documentation workflow
Transparent and competitive consultation-based compensation
Opportunity to expand your professional reach across Singapore

Doctor / Specialist

MantraCare is hiring qualified Doctors and Specialists to provide structured tel...

Location

Philippines

Salary:

Not provided

MantraCare

Expiration Date

Until further notice

Requirements

MBBS / MD or equivalent recognised medical qualification
Valid registration with the Philippines Medical Council (MMC)
Specialist certification in your respective field (for specialist roles)
Minimum 2 years of clinical experience preferred
Experience in teleconsultation is an advantage
Strong diagnostic and communication skills
Reliable internet connection and private WFH setup

Job Responsibility

Conduct online medical consultations in your specialty area
Diagnose and manage patient cases virtually
Review medical history and recommend appropriate investigations
Provide treatment plans and prescribe medications as per guidelines
Offer follow-up consultations and monitor progress
Maintain secure and confidential digital medical records
Follow Philippines healthcare regulations and ethical standards
Collaborate with multidisciplinary teams when required

What we offer

100% Remote Doctor Job in Philippines
Flexible working hours
Access to a growing national patient base
No clinic rent or administrative overhead
Secure telemedicine platform
Structured documentation workflow
Transparent and competitive consultation-based compensation
Opportunity to expand your professional reach across Philippines

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

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for Qualification & Validation Specialist

Commissioning & Qualification Specialist

Adhd Specialist Independent Prescriber

Regulatory Affairs Specialist

Senior Validation Specialist

Cqv Engineer

Doctor / Specialist

Doctor / Specialist

Doctor / Specialist

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

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for Qualification & Validation Specialist

Commissioning & Qualification Specialist

Adhd Specialist Independent Prescriber

Regulatory Affairs Specialist

Senior Validation Specialist

Cqv Engineer

Doctor / Specialist

Doctor / Specialist

Doctor / Specialist

Location:
Italy , Milano

Category:
Quality Control

Contract Type:
Not provided

Job Posted:
December 12, 2025