Quality Manager Specialist (CAPA and Change Management) Job at Aignostics (Berlin)

Quality Specialist – Product Compliance

Undertaken batch review for a variety of Products in Poland that require QP batc...

Location

Poland , Warsaw

Salary:

Not provided

Theramex

Expiration Date

Until further notice

Requirements

Experience working in Quality Function within the Pharmaceutical industry
Some experience of key areas of Quality Assurance and Pharmaceutical Quality Management Systems (Complaints, CAPA, Deviation, Change Control)
Basic Knowledge of the Pharmaceutical GxP regulations
Able to foster strong cross-functional relationships
Influence, interpersonal, verbal, and written communication skills
Able to respond positively to, and effectively implement, change
Digitally Savvy
Fluency in both English and Polish to handle communication with healthcare authorities in Poland
A degree or equivalent in a relevant scientific subject is desirable

Job Responsibility

Performing a review of manufacturing records for batches of medicinal products certified by Theramex QP
Batch Review all MIA Products Prior to QP Certification
Establish a close working relationship with the Contract Manufacturers and internal stakeholders (Supply Chain, Regulatory, Medical, Marketing) for assigned products
Investigation and resolution of complaints with CMOs
Determining and implementing robust CAPAs as required
Assessment and approval of deviations
Managing and approval of change controls
Creation and Maintenance of Quality / Technical Agreements
Ensuring CMO’s are supplied and adhere to Compliance Files / Marketing Authorisations
Support of on-site audits and visits

Qa quality specialist

This position reports to the Associate Director, External Quality, Quality Syste...

Location

Ireland , Cork

Salary:

Not provided

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

Bachelor’s Degree in science or engineering
Minimum 3+ years of biopharmaceutical experience in a Quality, Compliance, and/or Regulatory setting
Skilled in data analysis and excel
Strong communication and interpersonal skills – Oral, written and presentation skills
Works collaboratively with others to meet shared objectives.

Job Responsibility

Perform the Quality Systems Metric Review for External Quality and oversee relevant metrics and trending for each quality system to proactively drive on-time closure of Quality records
Responsible for managing routine cross-functional meetings to ensure timely closure of Deviations, CAPAs and Change Control, with leadership endorsement
Responsible for development/reporting of metrics and supporting standardization of these across the Organization
Co-ordinate monthly governance site quality review team (SQRT) meeting for GEO / External Quality
Deliver training on Quality Management Systems, as required
Partner with the Global Quality Systems Management Team and other cross functional groups to ensure proper application of the QMS
Identify and implement continuous improvement initiatives to the External Quality systems
Assist as needed in audits and inspections
Participate in development and implementation of global alignment projects with BioMarin’s sister sites
Manage the Self Inspection Programme for External Quality

QM Specialist (CAPA and Change Management)

As a QM Specialist (CAPA and Change Management) you'll own the development and e...

Location

Germany , Berlin

Salary:

Not provided

Aignostics

Expiration Date

Until further notice

Requirements

Proven expertise in quality management systems, CAPA methodologies, and change control processes
Strong proficiency with root cause analysis tools (5 Whys, Fishbone diagrams, Fault Tree Analysis)
Solid understanding of ISO 13485, ISO 14971, IEC 62304, IVDR, and 21 CFR Part 820
Experience planning, conducting, and supporting internal and external audits
Excellent written and verbal communication skills in English
Ability to influence and collaborate effectively with diverse stakeholders at all levels

Job Responsibility

Build Robust Quality Systems: Establish and maintain CAPA management systems in full compliance with ISO 13485
Design and oversee change management processes aligned with ISO 13485 and IEC 62304
Maintain comprehensive QM documentation including SOPs, work instructions, and quality records
Translate regulatory requirements (IVDR, ISO 13485, FDA QSR) into actionable QM system elements
Analyze quality and change data to identify trends, systemic issues, and improvement opportunities
Enable Cross-Functional Excellence: Partner with software engineers, data scientists, and product teams on root cause analysis and corrective measures
Coordinate and support internal and external audits (notified body, regulatory authorities)
Facilitate CAPA and change review meetings where diverse perspectives are heard and the best ideas win
Build collaborative relationships across all departments to embed quality thinking everywhere
Foster a Learning Culture: Develop and deliver training programs on CAPA management, change control, and quality processes

What we offer

Join a purpose-driven startup: We are working collectively to fight cancer and improve patient outcomes. Come help us make a difference!
Fun, cutting-edge AI research and development, with involvement of Charité, TU Berlin and our other partners
Work with a welcoming, diverse, and highly international team of colleagues
Ability to take responsibility and grow your role within the startup
Competitive remuneration package in addition to perks and benefits
Expand your skills by benefitting from our Learning & Development yearly budget of 1,000€ (plus 2 L&D days), language classes and internal development programs
Mentoring program, where you'll learn from and mentor great experts
Flexible working hours and teleworking policy
Enjoy your well-deserved time off with 30 paid vacation days per year
We are family & pet friendly and support flexible parental leave options

Fulltime

Quality Assurance Packaging Specialist

This position within the QA department provides Quality oversight, support and k...

Location

Ireland , Cork

Salary:

Not provided

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

Degree or 3rd level qualification (Science, Quality)
Demonstrated experience in packaging as the Quality contact for the area
Relevant experience (5yrs +) working in a Quality function in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the other requirements of the role
Demonstrates good knowledge of FDA / EMEA regulations/standards and quality systems
Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance
Demonstrated ability to work and succeed within teams as well as leading small project teams while maintaining and strengthening trust relationships with people on all levels
Strong organizational skills, including ability to follow assignments through to completion
Proficiency in PC skills such as Excel, Word, PowerPoint
Proven decision making capability with full accountability and responsibility
Demonstrated coaching skills

Job Responsibility

Provide Quality input and guidance to ensure packaging of high quality products in compliance with current Good Manufacturing Practices (GMPs)
Provide Quality direction and oversight of the development of new and existing processes in the packaging area to meet customer needs
Exercise judgment to determine appropriate action, ensuring proper escalation when non-conformances are identified as per applicable procedures for compliance, escalation and corrections within the packaging area of operations
Provide Quality input to Change Control/Deviations ensuring scope of record is clear and implementation activities are robust and timely
Review and approval of NCs and associated CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable
Participates within inter-departmental and cross-functional teams, with direct interface with Manufacturing, Supply & Distribution, Maintenance, Metrology and Quality Control employees to immediately address issues and questions in real time to help ensure timeline are achieved to meet customer requirements
Minimising impact to packaging operations on site
Prioritizes tasks to ensure the critical tasks are completed on time and meet requirements
Review and release inputs for use in manufacturing as required
Write, review and approve Standard Operating Procedures in accordance with BioMarin Policies

Fulltime

Quality Assurance Specialist

The Quality Assurance (QA) Technical Services Specialist is a critical role for ...

Location

United States , West Greenwich

Salary:

113191.00 - 131832.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED & 10 years of Quality and/or Manufacturing experience
Associate’s degree & 8 years of Quality and/or Manufacturing experience
Bachelor’s degree & 4 years of Quality and/or Manufacturing experience
Master’s degree & 2 years of Quality and/or Manufacturing experience
Doctorate degree
Demonstrated experience leading enterprise risk management within GxP environments
Experience supporting Product Reintroductions (PRIs) and New Product Introductions (NPIs)
Demonstrated abilities in problem solving, and experience managing deviation/change control/ CAPA
Excellent written and verbal communication skills with cross functional teams, network, and management
Proven ability to make informed risk-based decisions to drive continuous improvement and maintain quality and compliance

Job Responsibility

Provide quality advice and oversight to ensure products are manufactured, tested, stored, and distributed according to current good manufacturing procedures
Develop and maintain a working understanding of applicable requirements and best practices
Leverage knowledge and experience to provide risk-based Quality advice on strategies for successful investigation of deviations
as well as implementation of corrective actions, and change control
Manage the change control process, ensuring changes and implementation strategies are thoroughly evaluated for impact to quality
Perform review and approval of GMP processes, procedures, documents, and records, including deviations, corrective actions, change controls, effectiveness verifications, standard operating procedures, batch records, and protocols
Ownership and subject matter expertise of quality processes including Deviation, CAPA, EV, Change Control and Quality Risk Management
Collaborate with project teams to integrate quality considerations and controls into project planning and execution
Independently assess and prioritize quality risks across various functions and processes
Implement proactive measures to prevent potential issues and ensure a state of inspection readiness

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Senior QARA Specialist

This is where your work makes a difference. At Baxter, we believe every person—r...

Location

Algeria , Algiers

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Responsible for QA and RA communications with health authorities
Will be the nominated pharmacist in charge for Baxter's operating establishment
Will be the authorized signatory entity & official responsible pharmacist for all PVQARA communications
Will be nominated as Baxter's point of contact for all RA & QA activities in front of MOH
Assume the tasks of the Responsible Pharmacist of Baxter entity in Algeria as defined by the local regulations
Ensure company compliance with applicable Acts and regulations, and cGMP, in the control of medicines and medical devices distributed and sold by Baxter Healthcare
Prepare for MOH audits and ensure satisfactory outcomes
To keep awareness and being updated on relevant national Algerian and assigned countries’ legislation and inform ECEMEA cluster head and global teams about any relevant changes to the legislation
To ensure that CQA processes are in place in his / her region: Local Complaint Coordinator activity, Product Surveillance activity for Medicinal Products and Medical Devices, Field Action execution, Supplier & Distributor Management, Implementation of Baxter Quality System in the region and audit management, NCR, CAPA and Change Management, Selling Authorizations and release of products according to local requirements
Ensure back up persons for critical processes in the region are appropriately trained and back up are always available

Job Responsibility

Responsible for QA and RA communications with health authorities
Will be the nominated pharmacist in charge for Baxter's operating establishment
Will be the authorized signatory entity & official responsible pharmacist for all PVQARA communications
Will be nominated as Baxter's point of contact for all RA & QA activities in front of MOH
Assume the tasks of the Responsible Pharmacist of Baxter entity in Algeria as defined by the local regulations
Ensure company compliance with applicable Acts and regulations, and cGMP, in the control of medicines and medical devices distributed and sold by Baxter Healthcare
Prepare for MOH audits and ensure satisfactory outcomes
To keep awareness and being updated on relevant national Algerian and assigned countries’ legislation and inform ECEMEA cluster head and global teams about any relevant changes to the legislation
To ensure that CQA processes are in place in his / her region: Local Complaint Coordinator activity, Product Surveillance activity for Medicinal Products and Medical Devices, Field Action execution, Supplier & Distributor Management, Implementation of Baxter Quality System in the region and audit management, NCR, CAPA and Change Management, Selling Authorizations and release of products according to local requirements
Ensure back up persons for critical processes in the region are appropriately trained and back up are always available

Fulltime

Quality Assurance Specialist

Amaris Consulting is looking for a Quality Control Supply Chain Specialist to su...

Location

Belgium , Zaventem

Salary:

Not provided

Amaris Consulting

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Life Sciences, Engineering, Quality Management, Pharmacy, or a related field
4+ years of experience in Quality Assurance, Quality Control, or Supply Chain Quality within regulated industries
Hands-on experience with nonconformance management, CAPA, and root cause analysis
Solid knowledge of Quality Management Systems (QMS) and experience with QM software/tools
Strong analytical skills with experience in data trending, reporting, and Excel
Fluent in English, with a structured, proactive, and detail-oriented working style

Job Responsibility

Supporting international quality assurance activities related to supply chain and distribution processes
Reviewing and approving nonconforming material records, distribution holds, and deviation documentation
Supporting nonconformance management, including root cause analysis and CAPA activities within defined timelines
Reviewing quality documentation related to incoming and outgoing inspections, returns, and shipments
Monitoring and trending quality data, customer notifications, and quality performance indicators
Supporting quality audits, change initiatives, and continuous improvement projects
Ensuring compliance with established QMS procedures and regulatory requirements
Collaborating with internal and external stakeholders to promote quality awareness and process alignment

What we offer

performance bonuses
mobility options including lease cars

Safety Implementation Consultant - EHS

Location

United States , Atlanta

Salary:

Not provided

Proudfoot

Expiration Date

Until further notice

Requirements

Practical experience implementing safety management systems, safety operating models, or EHS governance frameworks in field-based or industrial environments
Hands-on experience coaching supervisors and managers in safety leadership behaviors — not just classroom training, but at the point of execution
Working knowledge of JHA, safety incident investigation (ECFA, 5 Why, Fishbone etc.), and Management of Change processes
Experience facilitating safety committees, management review meetings, or equivalent governance forums
Ability to train and coach diverse audiences (frontline supervisors, site managers, EHS specialists, union safety representatives) in practical, accessible language
Comfortable working on-site in field environments (utilities, energy, construction, mining, manufacturing, or similar sectors)
Strong interpersonal skills — ability to build credibility quickly with both frontline workers and senior leadership
Willingness to travel extensively (Monday–Friday on-site at client locations is the norm during implementation phases)
Experience with PDCA-based management systems (ISO 45001, OSHA VPP, or proprietary safety operating models)

Job Responsibility

Implement Safety Operating Models at client sites, including SQDC-P governance boards, Management Review Meetings (MRMs), Site Safety Committees, and escalation pathways
Coach supervisors, managers, and EHS specialists in the practical application of SQDCP, Safety Committee, and Management Review — Site, district, and corporate level Daily SQDC, Weekly Management Review and Bi-weekly Safety Committee
Job Hazard Analysis (JHA) — proactive risk identification, oversight, quality, and pattern analysis
Safety Incident Investigation— investigation and root cause analysis methods (Fishbone, 5 Whys, ECFA, CAPA management, and governance)
Management of Change (MOC) — change triggers and processes, decision-making authority, and change impact assessment, and qualitative review
Deliver training to groups of 20–30 participants using structured curricula, scenario-based practice sessions, and role-differentiated content
Use Coaching Assessment Tools to track supervisor and manager progression through implementation stages (Demonstrate → Joint Execution → Guided Practice → Independent Execution)
Facilitate daily SQDC-P meetings, weekly MRMs, and monthly governance reviews alongside client leaders — modeling effective meeting discipline and signal-to-action translation
Support the deployment of Sustaining Elements including Audits & Inspections (A&I), Behavioral Observation for Learning (BOL), and Six Minutes of Intensive Training (SMIT)
Build client capability through a Train-the-Trainer approach, coaching internal resources to deliver training and sustain the SOM independently

What we offer

The opportunity to do work that directly improves safety outcomes for thousands of frontline workers
A Shoulder-to-Shoulder implementation culture — we work in the field, not from a back office
Structured professional development within a global consulting firm with 80 years of operational transformation experience
Exposure to multiple industries, clients, and operational environments
A collaborative, expert team that values practical results over theoretical frameworks
Competitive compensation and benefits

Fulltime

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Quality Manager Specialist (CAPA and Change Management)

Job Description

Job Responsibility

Requirements

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