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Quality Specialist, QA Qualification

Lonza · Posted Nov 10, 2026

Open

San José, Costa Rica

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Quality Specialist, QA Qualification

Lonza · Posted Nov 10, 2026

Open

San José, Costa Rica

Apply with RefersoAI Apply on careers page

Quality Expert, QA Qualification

Lonza · Posted Nov 10, 2026

Open

San José, Costa Rica
Senior

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Provide Quality Assurance leadership for qualification and validation activities related to equipment, facilities, utilities, and computerized systems operating in cGMP environments.

Responsibilities

Provide Quality Assurance leadership for qualification and validation activities related to equipment, facilities, utilities, and computerized systems operating in cGMP environments.
Serve as the Global QA representative on cross-functional engineering and project teams, ensuring quality and compliance expectations are integrated throughout project lifecycles.
Review and approve commissioning, qualification, validation documentation, technical assessments, risk evaluations, and compliance strategies.
Guide functional teams and provide expert direction on commissioning, qualification, computer system validation (CSV), and enabling qualification activities.
Translate regulatory trends, inspection observations, and industry expectations into actionable quality improvements and compliance strategies.

Requirements

Bachelor’s in engineering, Biological Sciences, Chemical Sciences, Biotechnology, or relevant experience

Skills

Quality Assurance qualification validation

Quality Lead Specialist

GE HealthCare · Posted Nov 10, 2026

Open

Oslo, Oslo, Norway

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Lead specialist responsible for quality systems and regulatory compliance in sterile and aseptic pharmaceutical manufacturing.

Responsibilities

Take overall responsibility for systems ensuring compliance with GMP requirements and quality standards within sterile and aseptic pharmaceutical manufacturing.
Support the quality assurance of SAP-related processes and the approval of artwork and packaging materials in collaboration with relevant functions and the wider team.
Contribute to change control activities through risk-based assessments and quality approval of changes, ensuring appropriate follow-up through to closure.
Further develop and manage quality systems, including deviation management, CAPA, risk management, document control, and training systems, ensuring they are effective, risk-based, and compliant with regulatory requirements.
Provide quality assurance support and subject matter guidance to manufacturing areas, laboratories, and support functions.

Requirements

Master’s degree in pharmacy, chemistry, biotechnology, engineering, or another relevant field
Nice to have: SAP quality-related processes
Nice to have: approval of artwork, labels, or packaging materials
Nice to have: Operational Excellence
Nice to have: continuous improvement initiatives

Skills

GMP regulations EU GMP Annex 1 deviation management CAPA change control internal audits risk management document control training systems Excel pivot tables charts dashboards LEAN principles structured problem-solving

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Director, External Quality Management

Amneal · Posted Nov 9, 2026

Open

Piscataway, New Jersey, United States
Manager
$205K–$236K per year
15+ years

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Lead the External Quality team overseeing quality oversight of Amneal's network of external manufacturers, ensuring compliance with cGMP and regulatory requirements.

Compensation

The salary range for this position ranges from $205,000 - $236,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award as well as a long-term incentive award, such as restricted stock units, with this position within the first 12 months.

Responsibilities

Lead quality oversight of 50+ external manufacturers, contract laboratories, and business partners
Establish risk-based oversight model and audit program
Serve as senior quality decisionmaker for external manufacturing issues
Represent External Quality in management review and Quality Council forums
Lead, coach, and develop a team of External Quality Managers and QA Leads

Requirements

Bachelor's Degree in Chemistry, Biology, Pharmacy, Engineering or other technical fields
Master's degree in Chemistry, Biology, Pharmacy, Engineering or other technical fields
Nice to have: Master's degree

Skills

quality oversight CMO network oversight FDA inspections

Specialist, Complaints, Quality

West Pharmaceutical Services · Posted Nov 6, 2026

Open

Dublin, Leinster, Ireland
Hybrid
€48K–€61K per year
2+ years

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Ensure internal system compliance and customer specifications conformity, support complaint handling and regulatory reporting activities.

Compensation

The annual base salary range for this position is €48,000.00 - €61,100.00. Total target compensation is determined using objective and gender-neutral criteria, including relevant experience, qualifications, skills, market benchmarks, geographic location, and the scope and responsibilities of the role.

Responsibilities

Coordinate and support complaint handling of product complaints received by customers
Interface with customers to ensure requirements and concerns are communicated and corrective actions are closed
Open, track and maintain records for complaints
Data entry into complaint handling system
Conduct DHR review of Medical Device within the QMS

Requirements

Third level qualification in Engineering/Quality/Science
Nice to have: knowledge of 21 CFR Part 820
Nice to have: knowledge of EU GMP

Skills

ISO 13485 21 CFR Part 820 EU GMP complaint handling CAPA

QC Manager

Chanelle Pharma · Posted Nov 5, 2026

Open

Loughrea, Connacht, Ireland
On-site
Full-time · Manager
5+ years

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Lead Quality Control laboratory operations ensuring compliance with GMP, GLP, EU and US regulatory requirements.

Responsibilities

Lead and develop laboratory team
Oversee analytical activities and laboratory performance
Drive continuous improvement
Ensure compliance with EU and US regulatory requirements
Maintain QC stability testing program

Requirements

Bachelor’s degree in a science-based discipline

Skills

GMP GLP EU GMP US FDA Guidelines MS Office analytical skills root cause investigation method development validation SOP

Head of Engineering

Teva Pharmaceuticals · Posted Nov 5, 2026

Open

Full-time · Executive
10+ years

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The Head of Engineering provides strategic and operational leadership for all engineering functions at the biopharmaceutical manufacturing site and is responsible for the performance and results of the Engineering department in accordance with the site's strategy.

Responsibilities

Oversee engineering maintenance and facility management activities, including engineering projects, production equipment, utilities and facility maintenance.
Plan, validate, control and approve all engineering decisions, documentation, resources, budget and forecasts.
Ensure equipment, systems and all facility-related issues are adequately handled in compliance with Quality, EHS&S and cGMP guidelines.
Implement, localize and maintain Teva Engineering standards and EHS&S standards, ensuring site compliance with relevant global and local legislation.

Requirements

Nice to have: Upstream cell culture
Nice to have: Downstream purification
Nice to have: Fill-finish
Nice to have: Automation
Nice to have: MES

Skills

FDA regulations EU GMP ICH regulations Biopharmaceutical unit operations

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