Deviation Maintenance Pharma Job at Amaris Consulting (Brussels)

Quality Manager

The Quality Manager & RP supports the Responsible Person in maintaining complian...

Location

United Kingdom , Kettering

Salary:

Not provided

Healthxchange

Expiration Date

Until further notice

Requirements

Batchelors degree in related field (Quality Assurance, life sciences etc)
Minimum of 3 years’ experience in a QA role in pharma industry (GDP, GMP, GxP)
Experience in GxP QMS management
Previous RP experience on WDA(H) (preferably with the same licence conditions)
Strong analytical, problem-solving and decision-making skills
Effective communication and interpersonal skills
Excellent attention to detail with strong analytical skills
Ability to work independently and collaboratively across multiple cross-functional departments
Preferred knowledge of Lean Six Sigma principles and methodologies
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint)

Job Responsibility

Support the implementation & maintenance of Healthxchange’s commitment towards GDP, GMP and GPhC Regulatory standards
Provide daily support towards Healthxchange’s operations licences at all sites
namely WDA(H) & MS licenses
Assist the Head of Quality in implementing and maintaining applicable standards across all Healthxchange operations
Act as the Responsible Person
Oversight and maintenance of the Quality Management System (QMS) including document control, change management, deviation and CAPA management, complaint management and validation activities
Assist in the development and improvement of procedures, protocols and departmental documentation
Support customer, supplier qualification and re-qualification
Outsourced activities qualification
Partake and support internal and external audits to assess compliance whilst continually removing risk from Healthxchange operations

What we offer

Company pension
annual performance bonus
25 days holiday plus bank holidays (and increasing with service)
staff discount
staff social events
access to Health Assured EAP

Fulltime

Quality Assurance Manager, Global Compliance

We are seeking a dynamic and collaborative Quality Assurance Manager to lead Glo...

Location

Canada , Wasaga Beach

Salary:

100000.00 - 120000.00 USD / Year

Randstad

Expiration Date

July 12, 2026

Requirements

3–5 years of leadership experience in a Quality role within a Health Canada or U.S. FDA regulated industry (Pharma or Food preferred)
Bachelor of Science (B.Sc.) or higher in a related scientific field
Deep understanding of GMP (Good Manufacturing Practices), Health Canada regulations, and EU GMP
High proficiency in Microsoft Office Suite
experience with Trackwise and SAP is highly desirable
Exceptional project management, critical thinking, and the ability to communicate complex regulatory requirements to senior stakeholders
ASQ certification is considered a strong asset
Ability to travel as needed and work flexible hours to meet global project deadlines

Job Responsibility

Maintenance and evolution of the Quality Management System to ensure adherence to Health Canada and U.S. FDA requirements within the pharmaceutical and food sectors
Ensure strict compliance with SOPs and governing body regulations (GMP/GLP)
Oversee global records management and the implementation/maintenance of the eQMS (Trackwise)
Host and lead regulatory inspections and customer audits
manage the internal audit program and ensure timely closure of CAPAs
Lead investigations and material review assessments for complaints, deviations, and non-conformances
Work cross-functionally to approve change controls, product specifications, and SOPs
Develop QMS training programs and monitor ongoing compliance through KPI analysis and quality trend reporting
Assist site teams with engineering protocols, equipment/process validations, and supplier quality management

What we offer

Access to a robust health and dental package
Professional development opportunities

Fulltime

QA C&Q Engineer Pharmaceuticals

We are looking for a CAR‑T QA C&Q Engineer to join the CAR‑T QA Qualification te...

Location

Belgium , Ghent

Salary:

Not provided

Amaris Consulting

Expiration Date

Until further notice

Requirements

Master’s degree in Engineering (with chemistry or analytical background) or in Pharmaceutical Sciences
4–6 years of experience in a GMP‑regulated environment, ideally within biotech, pharma, or advanced therapies (cell/gene therapy is a plus)
Solid awareness of quality and strong knowledge of cGMP regulations
Understanding of FDA/EU guidance related to manufacturing of cell therapy products
Ability and motivation to defend quality strategies and documentation during health authority inspections
Affinity with computerized systems and data management in critical production assets: System parameter configuration, Data integrity principles and controls
Strong analytical thinking and risk assessment capabilities
Excellent communication skills, both written and verbal
Proven collaboration and teaming skills
able to work cross‑functionally in a dynamic, continuously changing environment

Job Responsibility

Review and approval of qualification and requalification activities related to Facilities & Utilities (F&U) and Process Equipment at the CAR‑T manufacturing facilities
Work closely with Make Asset Management (MAM) and Engineering & Property Services (E&PS) to guard the qualification status of critical production assets
Ensure all system critical aspects related to facilities & utilities, product, and process requirements are identified, qualified, and controlled via appropriate mitigation plans
Ensure deviations related to equipment issues with potential impact on quality and/or compliance are evaluated, thoroughly investigated, and that adequate corrective and/or preventive actions (CAPA) are defined and implemented
Collaborate with the manufacturing department to review and approve new change controls
Ensure deviations with potential impact on quality and/or compliance are evaluated, investigated, and addressed with appropriate CAPAs
Build strong connections with different quality organizations and stakeholders
Manage the compliance status of critical production assets by reviewing and approving procedures
Overseeing master data set‑up, maintenance plans, and daily operations activities
Reviewing and approving data integrity deliverables such as system audit trail and user access reviews

What we offer

Rapid growth opportunities
Prestigious projects with renowned clients
International environment

Fulltime

Pharma QC Supervisor

A manufacturer of specialist pharmaceuticals are currently seeking a QC Supervis...

Location

United Kingdom , Guildford

Salary:

35000.00 - 45000.00 GBP / Year

Network Scientific Recruitment

Expiration Date

Until further notice

Requirements

Prior experience with HPLC and GC in an industrial setting is essential
Ideally within pharmaceutical/aseptic manufacturing
Prior experience with environmental monitoring highly beneficial
Educated to Degree level or equivalent in relevant Analytical Chemistry related discipline is essential
Must be able to work shifts that include nights
Must be able to work occasional Saturday work (overtime)

Job Responsibility

Routine Analysis of pharmaceutical products in line with cGMP and company standards
Utilise a range of analytical techniques and equipment including HPLC, GC, RTLC, LAL and Gamma Spectrometer
Environmental monitoring
Take part in maintenance and calibration of analytical equipment
Take part in deviations, change controls and other quality processes, working closely with QPs
Supervise the QC department

What we offer

Clear progression and development opportunities

Fulltime

Quality Manager & Responsible Person (RP)

The Quality Manager & RP supports the Responsible Person in maintaining complian...

Location

United Kingdom , Northampton

Salary:

Not provided

Healthxchange

Expiration Date

Until further notice

Requirements

Batchelors degree in related field (Quality Assurance, life sciences etc)
Minimum of 3 years’ experience in a QA role in pharma industry (GDP, GMP, GxP)
Experience in GxP QMS management
Previous RP experience on WDA(H) (preferably with the same licence conditions)
Strong analytical, problem-solving and decision-making skills
Effective communication and interpersonal skills
Excellent attention to detail with strong analytical skills
Ability to work independently and collaboratively across multiple cross-functional departments
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint)

Job Responsibility

Support the implementation & maintenance of Healthxchange’s commitment towards GDP, GMP and GPhC Regulatory standards
Provide daily support towards Healthxchange’s operations licences at all sites
namely WDA(H) & MS licenses
Assist the Head of Quality in implementing and maintaining applicable standards across all Healthxchange operations
Act as the Responsible Person
Oversight and maintenance of the Quality Management System (QMS) including document control, change management, deviation and CAPA management, complaint management and validation activities
Assist in the development and improvement of procedures, protocols and departmental documentation
Support customer, supplier qualification and re-qualification
Outsourced activities qualification
Partake and support internal and external audits to assess compliance whilst continually removing risk from Healthxchange operations

What we offer

Company pension
annual performance bonus
25 days holiday plus bank holidays (and increasing with service)
staff discount
staff social events
access to Health Assured EAP

Fulltime

Executive- Engineering QMS

JLL empowers you to shape a brighter way. Our people at JLL are shaping the futu...

Location

India , Mumbai

Salary:

Not provided

JLL

Expiration Date

Until further notice

Requirements

BE Mechanical/Electrical/Instrumentation or B pharma …preferably BE
6-7 years experience in handling engineering department GMP documentation activities and supporting engineering function as SME in QMS documentation

Job Responsibility

Implementation of quality assurance standards, processes, controls and cGMP in warehouse
Preparation of SOPs and ensure effective implementation
should be well versed with deviation management SOP
Should be well versed with change control and CAPA management related to engineering department
Should be familiar with documentation like DQ, IQ, OQ and PQ
To ensure that training for SOP’s, GDP, cGMP and On the Job training are imparted to staff as per Schedule
Routine Requalification & Validation of HVAC systems, compressed gases and equipment
Preparation of all planners like Preventive maintenance, calibration, requalification etc in engineering function
To ensure compliance to Regulatory, ISO and WHO GSDP requirements
should coordinate for the drawing preparation and approvals

Fulltime

Engineering Supervisor

Hands on maintenance with ability to maximize machine reliability and throughput...

Location

Ireland , Dundalk

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Mentoring & coaching skills
Highly motivated with proven ability to work on own initiative
Excellent communication skills
Excellent problem-solving skills
Trades background and at least 5 years team leader experience in a GMP environment
Engineering degree - Level 7

Job Responsibility

Ensure team has carried out all planned tasks such as PM’s and work orders
Monitor employees' work levels and review work performance on an ongoing basis
Raise purchase requisitions through the CMMS
Ensure full adherence all team members on their safety training
Assist in various projects
Train team members where necessary
Provide feedback for employee reviews
Assist Facility Manager in any tasks required
Ensure CAPA's are complete
Ensure team’s time keeping is punctual and report any issues

Fulltime

QA Specialist

You will be a member of Pfizer’s dedicated and highly effective quality assuranc...

Location

Ireland , Dublin; Newbridge; Shanbally; Ringaskiddy; Little Island

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Relevant Third Level Qualification or Equivalent (Exceptions may be considered where relevant skills/experience and correct attitude and behaviours exist (this may be supplemented by further education in parallel)
Minimum 2 years experience as detailed above in the job responsibilities section, within a QA/QC GMP environment in a Pharma/Biotech company
Excellent communication and interpersonal skills
An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment
Proactive approach and strong critical thinking skills

Job Responsibility

Support operations through real time batch review ensuring all batch manufacturing records (paper / electronic) and associated manufacturing deviations are reviewed in a timely manner and in accordance with release schedules
Support issue resolution, incident routing and deviations
Complete walkthrough audits to ensure the area is maintaining cGMP compliance standards
Attend IMEx meetings and ensure timely escalation of issues to the QA Manager
Accurately communicate Supply/Operational needs/perspectives as well as Quality Operations (QO) perspectives
Review and approval of validation documents Process, cleaning & method validation
Review and approve master batch records and executed batch records to assure compliance with regulatory standards and regulatory filings
Ensure that production instructional documentation (SOPs and batch records) are up to date, compliant, and supports RFT (right first time) production, and that all in -process control limits and specifications have been met
Review all operational SOP’s, forms, protocols and reports, and any related documentation as applicable
Ensure all batch deviations are reported in accordance with Pfizer corporate standards

Fulltime

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Deviation Maintenance Pharma

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