GMP QA Site lead Job at Amaris Consulting (Mechelen)

Qa Process Leader

As QA Process Leader you’ll be working as part of the Technical Department, veri...

Location

United Kingdom , Wednesbury

Salary:

14.25 GBP / Hour

Avara Foods

Expiration Date

Until further notice

Requirements

Good knowledge of processes and products
Previous experience of working in a QA role
Accuracy and attention to detail
Ability to work independently but also as part of a team
Organisational skills and ability to plan own workload
Problem solving techniques

Job Responsibility

Lead the Quality Auditors to always operate in a safe manner
Delivering training of technical task procedures to colleagues and completing competency assessments where needed
Monitor and review QA’s weekly task list and ensure good communication between all shifts
Monitor and audit Production Operations to ensure that customer requirements are understood and achieved
Managing the NC’s log for products on hold, ensuring the release, rework, repack and disposal of products in a timely manner, liaising with planning, production and despatch
Inspecting product against customer quality contract agreements
GMP Audits – conduct against a scheduled frequency to ensure good manufacturing practice at site
Complete required audits such as hygiene audits, glass & plastics, fabrication audits and CCP audits in line with site procedures
Ensure all paperwork is completed in full, in line with company procedures and legal requirements
Carry out verification checks of calibration of measuring equipment in accordance with the schedule

What we offer

Shift allowance of an extra £2 per hour for hours worked between 6pm -6am
Paid Weekly
Overtime available
Training and development from day one
Secure contract, guaranteed hours and opportunities for overtime

Fulltime

Quality Assurance (QA) Lead Coordinator

The Quality Assurance (QA) Lead Coordinator is responsible for establishing, imp...

Location

United States , Port Neches

Salary:

Not provided

Airswift Sweden

Expiration Date

Until further notice

Requirements

Establish, implement, and maintain the Quality Management System (QMS)
Ensure compliance with regulatory, customer, and internal requirements
Drive continuous improvement within the Quality and Food Safety System
Oversee validation activities
Lead product safety initiatives
Manage audits, compliance, supplier oversight, and QMS certification programs
Define and monitor KPIs with a continuous improvement focus
Maintain and control the Document Management System
Ensure compliance with the Quality and Safety Management System
Sustain existing certifications and drive corrective actions based on risk and nonconformity analysis

Job Responsibility

Define and monitor KPIs with a continuous improvement focus
Maintain and control the Document Management System
Ensure compliance with the Quality and Safety Management System
Sustain existing certifications and drive corrective actions based on risk and nonconformity analysis
Implement new certifications aligned with strategic objectives
Ensure compliance with all applicable standards
Implement GMP practices across QA
Lead quality initiatives and training programs
Manage budgets and invoice processes
Provide QA-related support to cross-functional teams

Director of Quality

Mantell Associates is partnered exclusively with a globally operating CDMO to re...

Location

United States , Massachusetts

Salary:

Not provided

Mantell Associates

Expiration Date

Until further notice

Requirements

Significant quality leadership experience within a CDMO, pharmaceutical or biotechnology manufacturing environment – CDMO experience strongly preferred
Proven experience leading site-level quality operations at scale, ideally within a large, complex GMP manufacturing facility
Hands-on experience across both biologics/mAb and small molecule modalities
Deep knowledge of FDA GMP regulations (21 CFR Parts 210/211/600) and relevant ICH guidelines
Demonstrated experience managing FDA inspections with a strong track record of successful outcomes
Proven QC oversight experience, with a solid understanding of analytical operations and laboratory compliance
Strong client-facing skills with the ability to build credibility and trust at a senior level
Exceptional leadership and people management skills, with experience developing large, diverse quality teams
Strategic thinker with the operational presence to engage credibly at all levels of a large manufacturing site
Bachelor’s degree or above in a relevant life sciences discipline

Job Responsibility

Own and drive the site QMS, ensuring all systems, processes and documentation are robust, inspection-ready and aligned with global quality standards
Lead site GMP compliance across biologics/mAb and small molecule manufacturing operations, ensuring adherence to FDA regulations and ICH guidelines
Oversee the site CAPA programme, deviation management and change control processes, ensuring issues are investigated thoroughly and resolved effectively
Drive a proactive, right-first-time quality culture across all site functions, from manufacturing and QC through to supply chain and engineering
Provide strategic and operational oversight of the site QC function, ensuring analytical testing, raw data review and results reporting meet the highest standards of accuracy and compliance
Partner with QC leadership to ensure laboratory operations are fully compliant, inspection-ready and continuously improving
Oversee out-of-specification (OOS) and out-of-trend (OOT) investigations, ensuring robust root cause analysis and appropriate corrective actions
Serve as the site quality authority for all regulatory matters, leading preparation for and management of FDA inspections and any other relevant agency interactions
Provide quality oversight and input into regulatory submissions, ensuring site-level documentation and data packages meet agency expectations
Monitor the evolving regulatory landscape and proactively update site quality systems and practices to maintain compliance

Sr. QA Specialist - Ops

The Sr. QA Specialist – Team Lead will work with other departments to ensure the...

Location

United States , Bedford

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

7-9 years of pharmaceutical or biotech industry
4+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production
Bachelor’s Degree in a relevant scientific discipline preferred
Experience performing RCA, technical writing, and working with quality related investigations
Knowledge of laboratory and production equipment and IQ/OQ/PQ
Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH
Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9
Ability to Travel 10%

Job Responsibility

Perform review of batch documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements. Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization
Review and approve master batch records for the timely initiation of GxP manufacturing activities
Responsible for quality oversight and administration of the deviation/investigation and CAPA programs
Review and approve Manufacturing, Quality Control, and other investigations in support of batch release and GMP compliance
Provide direction for complex investigations and CAPAs
Ensure timely, accurate and complete execution and documentation of quality system events: deviations, NCMRs, GxP investigations and CAPAs
Review, develop, and improve quality system procedures, specifications, and test methods
Review and approve CAPAs to prevent recurrence of deviations
Review and approve Change Control documentation
Responsible for tracking investigations and change control for timely completion. Provide status reports, including relevant quality metrics and participate in the management review process

Fulltime

Senior QA Executive 1

You will play a key role in ensuring quality and compliance in a modern manufact...

Location

Singapore , Tuas

Salary:

Not provided

GSK

Expiration Date

Until further notice

Requirements

Bachelor’s degree in science, microbiology, biotechnology, pharmacy, engineering, or a related discipline
At least 6 years of experience in quality assurance within the pharmaceutical or biologics industry
Strong knowledge of GMP and regulatory requirements relevant to manufacturing and quality
Practical experience with deviations and CAPA processes
Experience with validation, qualification and change control practices
Good written and verbal communication skills in English

Job Responsibility

Provide QA oversight - Sterility Assurance for site manufacturing processes and products manufactured by the site
Provide QA oversight – Quality control laboratory for Microbiology and Endotoxin tests
Develop, implement, and monitor sterility assurance programme on site
Lead sterility assurance activities: sterile process oversight, container closure integrity (CCI) strategies, aseptic process simulation (media fills), and bioburden or sterility-related investigations
Develop, review and approve microbiology and sterility-related SOPs, specifications, and test methods
ensure documentation is current and GxP-compliant
Provide technical direction for microbiology method development, transfer, validation, troubleshooting, root cause analysis, and corrective/preventive actions (CAPA)
Manage deviations, OOS/OOT events and non-conformances related to microbiology and sterility
lead investigations and ensure timely regulatory-compliant reporting
Establish and maintain environmental monitoring programmes

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes

Fulltime

QA Manager

This position requires a broad experience in working in a GMP environment and fa...

Location

United States , Lafayette, IN

Salary:

Not provided

Evonik Industries

Expiration Date

Until further notice

Requirements

BS in chemistry, engineering, science, or equivalent experience
8+ years industrial experience in a GMP environment preferred
Extensive GMP compliance knowledge for products such as APIs, Food Additives, Excipients
Ability to apply compliance standards to production
Strong communication and leadership skills
Ability to work in undefined environments
Must provide 24/7 coverage as needed

Job Responsibility

Ensure production areas receive the resources and QA support needed to maintain GMP compliance while meeting batch release timelines
Lead performance planning, goal accountability, and development for all direct reports, providing consistent coaching and mentoring
Foster collaboration between QA Project Managers and Production QA Representatives to support product transfers that meet customer expectations and regulatory requirements
Build and maintain a qualified QA production support team through strategic staffing, training, and organizational development
Drive continual improvement of the Site Quality Management System in alignment with cGMP standards (ICH Q7, ISO 9001, Food GMP) and corporate Health Care quality systems
Ensure compliance with all internal, customer, and regulatory quality commitments while supporting internal/external audits and authority inspections
Maintain and report key KPIs, lead departmental improvement initiatives—especially those focused on efficiency and digitalization—and stay current on GMP trends
Oversee development of GMP paper/electronic data systems and provide delegated backup support for the Quality Assurance Director

What we offer

performance-based remuneration
occupational health benefits
hybrid and flexible working environments
attractive career paths
high-quality development programs

Fulltime

QA Specialist I - Operations

The QA Specialist will work with other departments to ensure the quality of prod...

Location

United States , Madison

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Experience performing RCA, technical writing, and working with quality related investigations
Knowledge of laboratory and production equipment and IQ/OQ/PQ
Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH
Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9
Bachelor’s Degree in a relevant scientific discipline preferred with a minimum of 3-5 years of pharmaceutical or biotech industry experience with 2+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production
ASQ certification preferred
Exceptional organizational skills and attention to detail
Ability to make risk based decisions and resolve issues with minimal guidance
Excellent interpersonal skills and the ability to communicate well orally and in writing
Proficiency in MS Office including Word, Excel, Access and Visio

Job Responsibility

Perform review of batch documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements
Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization
Review and approve master batch records for the timely initiation of GxP manufacturing activities
Responsible for quality oversight and administration of the deviation/investigation and CAPA programs
Review and approve Manufacturing, Quality Control, and other investigations in support of batch release and GMP compliance
Provide direction for complex investigations and CAPAs
Ensure timely, accurate and complete execution and documentation of quality system events: deviations, NCMRs, GxP investigations and CAPAs
Review, develop, and improve quality system procedures, specifications, and test methods
Review and approve CAPAs to prevent recurrence of deviations
Review and approve Change Control documentation

Fulltime

Sr. QA Specialist - Ops

The Sr. QA Specialist – External Operations will work with other departments to ...

Location

United States , Bedford

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

7-9 years of pharmaceutical or biotech industry
4+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production
Bachelor’s Degree in a relevant scientific discipline preferred
Experience performing RCA, technical writing, and working with quality related investigations
Knowledge of laboratory and production equipment and IQ/OQ/PQ
Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH
Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9
Ability to Travel 10%

Job Responsibility

Perform review of batch documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements. Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization
Review and approve master batch records for the timely initiation of GxP manufacturing activities
Responsible for quality oversight and administration of the deviation/investigation and CAPA programs
Review and approve Manufacturing, Quality Control, and other investigations in support of batch release and GMP compliance
Provide direction for complex investigations and CAPAs
Ensure timely, accurate and complete execution and documentation of quality system events: deviations, NCMRs, GxP investigations and CAPAs
Review, develop, and improve quality system procedures, specifications, and test methods
Review and approve CAPAs to prevent recurrence of deviations
Review and approve Change Control documentation
Responsible for tracking investigations and change control for timely completion. Provide status reports, including relevant quality metrics and participates in the management review process

Fulltime

GMP QA Site lead

Amaris Consulting

Location:
Belgium , Mechelen

Category:
-

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
April 05, 2026

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