Senior QA Specialist Job at Pfizer (Tuas)

Senior Specialist, QA External Manufacturing

The Senior QA Specialist – External Manufacturing is responsible for ensuring qu...

Location

Italy , Pomezia

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biology, Engineering, or a related field
3–5+ years of experience in a GMP Quality Assurance role within the pharmaceutical or CHC industry
Experience in external manufacturing or supplier quality (strongly preferred)
Solid knowledge of EU/FDA GMP regulations, ICH guidelines, and quality management systems
Strong ability to review complex documentation with accuracy and attention to detail
Problem-solving skills with experience in root cause analysis
Excellent communication skills to effectively interface with internal stakeholders and external partners
Ability to manage multiple priorities and work independently with moderate supervision
Familiarity with digital quality tools and AI applications
Proficiency in English

Job Responsibility

Serve as the primary QA contact for assigned CMOs, monitoring performance through quality metrics, documentation review, and regular governance meetings
Support batch review and release activities, ensuring thorough evaluation of manufacturing and packaging records, analytical results, deviations, and associated changes
Review and manage deviations, investigations (including OOS/OOT), and CAPAs, ensuring scientific soundness, robustness, and timely closure
Assess change controls from CMOs, collaborating with cross-functional teams (Regulatory, MS&T, Supply Chain, Procurement) to ensure compliant implementation
Participate in internal audits, CMO audits, and regulatory inspection readiness activities, following up on corrective actions
Maintain and update Quality Agreements to reflect current operations and compliance requirements
Drive continuous improvement initiatives related to quality systems and external manufacturing performance
Support technology transfers, scale-ups, and new product introductions from a QA perspective
Partner with Technical Operations and MS&T to enhance processes and product quality

What we offer

Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development

Senior QA Specialist (CMO Oversight)

Join our client with this QA position and play a key role in maintaining top-tie...

Location

United Kingdom , Uxbridge

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Strong knowledge of cGMP/GDP regulations for the USA, EU, and international markets
Ability to balance business targets with scientific and quality decisions
Excellent analytical, problem-solving, and project management skills
Strong communication and organizational abilities
Experience in developing and executing pharmaceutical quality systems
Proficiency in computer systems
Degree in a scientific discipline (BSc or equivalent)
Technical expertise in chemical, biological, and/or pharmaceutical operations
Experience interacting with Health Authorities (e.g., FDA, EMA) and supporting inspections
Proven ability to manage quality at external manufacturing sites

Job Responsibility

Manage contractor quality assurance activities to ensure compliance with regulatory and corporate requirements
Build and maintain strong working relationships with contractors
Lead discussions on quality-related topics such as complaints, change control, deviations, and documentation
Recommend and oversee quality-related improvements at contractor sites
Review batch records, including master production-packaging records and executed batch records, for GMP compliance
Manage and monitor change control requests, including evaluation, approval, and progress tracking
Support and approve complaint investigations related to external vendors
Review, edit, and approve contractor documentation, including validation protocols, reports, and investigations
Lead the review of Annual Product Quality Review reports and negotiate improvements with contractors
Draft, review, and recommend approval for Quality Agreements

Senior QA Specialist – Supplier Audits

This role is instrumental in strengthening supplier quality and compliance acros...

Location

United States , California

Salary:

Not provided

Mantell Associates

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Life Sciences, Engineering, Chemistry, or related discipline
Significant experience in supplier quality, audits, and quality systems within a pharmaceutical, biopharmaceutical, or CDMO environment
Strong knowledge of cGMP, ICH, regulatory expectations, and quality risk management principles
Demonstrated ability to lead supplier audits and effectively communicate findings to technical and operational stakeholders
Excellent analytical, report writing, and interpersonal skills with a proactive, solutions-oriented mindset
Ability to travel as required to support supplier audit activities (domestic and, occasionally, international)

Job Responsibility

Plan, execute, and lead supplier audits (on-site and remote) in accordance with cGMP, ISO standards, and internal procedures
Evaluate supplier quality systems, processes, corrective actions, and risk controls to ensure compliance and robust supply continuity
Prepare comprehensive audit reports, findings, and recommendations, and drive closure of audit observations with stakeholders
Support supplier qualification activities, including documentation review, risk assessments, and technical evaluations
Collaborate with Quality, Procurement, Regulatory, and Manufacturing teams to escalate supplier risks and implement mitigation strategies
Maintain audit schedules, quality intelligence, and supplier performance metrics to support continuous improvement
Serve as a subject matter expert on supplier quality expectations, training internal partners as needed

Fulltime

Senior Core QA Specialist - Software Test Engineering

As a Senior Infotainment Test Automation Engineer, you will play a key role in d...

Location

Canada , Markham

Salary:

104000.00 - 154000.00 USD / Year

General Motors

Expiration Date

Until further notice

Requirements

6+ years of embedded software QA/test experience in the mobile or automotive industry
3+ years of hands-on experience testing Android code (applications, frameworks, or services)
3+ years of technical leadership experience, including mentoring or guiding junior team members
Strong knowledge of software quality assurance methodologies, test design techniques, and QA tools
Proven experience with test automation frameworks such as Robot Framework and/or Appium
Excellent programming skills in Python and/or Java for building automation, tools, and scripts
Understanding of Scrum/Agile software development practices and working within cross-functional agile teams
Outstanding verbal and written communication skills
Strong problem-solving, analytical, and debugging skills
Demonstrated collaboration skills

Job Responsibility

Define the end-to-end test strategy and test plans for infotainment applications based on product roadmaps and release milestones
Identify test coverage goals and balance manual vs automated testing
Design and document detailed test cases and test scenarios from requirements and user stories
Execute smoke, sanity, regression, performance, stability, and exploratory tests
Build and maintain test automation frameworks (e.g., Robot Framework, Appium)
Develop and enhance test tools, utilities, and scripts
Design and maintain automation pipelines for different test types
Set up, configure, and maintain required test environments, devices, benches, and test equipment
Troubleshoot environment issues
Prepare clear, comprehensive test reports and dashboards

What we offer

Paid time off including vacation days and holidays
Supplemental benefits for pregnancy, parental, and adoption leave
Comprehensive healthcare, dental, and vision coverage
Life insurance plans for you and your family
Defined Contribution Pension Plan with company and matching contributions
GM Vehicle Purchase Program for you, your family, and friends

Fulltime

QA Specialist (In-Home Care QA visits)

This position will be responsible for conducting in-home visits at clients' home...

Location

United States , Truth Or Consequences

Salary:

Not provided

Arcadia Home Care and Staffing - an Addus family company

Expiration Date

Until further notice

Requirements

Minimum of 3 years’ experience working in the field of senior services or a related social service field
Excellent oral and written communication skills
Strong interpersonal skills
Ability to prioritize and handle high call volumes
Client-focused and customer service-driven
Proficient in Microsoft Word, Excel, and Outlook
Must have reliable transportation, valid driver’s license and insurance for travel within the branch service area

Job Responsibility

Monitors client’s condition and performance of duties by Home Care Aides
Maintains all company and Department on Aging rules, regulations, and standards
Conducts home visits to new clients to welcome and review the Welcome Packet
Observes and evaluates Home Care Aides in the client's home as directed by Supervisor, to assure client Care Plans are being followed
Prepares and completes accurate evaluation reports and case notes as needed
Maintains schedules to assure timely completion of all assigned home visits
Attends weekly branch meetings
Maintains a high degree of confidentiality at all times due to access to sensitive information
Maintains regular, predictable, consistent attendance and is flexible to meet the needs of the department
Follows all Medicare, Medicaid, and HIPAA regulations and requirements

What we offer

Medical, Dental and Vision Benefits
Company matched 401K
Continued Education
Bonus
PTO Plan
Retirement Planning
Life Insurance
Employee discounts

Fulltime

NDI Senior Specialist

Location

Saudi Arabia , Taif

Salary:

350.61 GBP / Day

Morson Talent

Expiration Date

Until further notice

Requirements

Have at least 7 years post qualification practical maintenance experience within operational flying aircraft environment supported by formal recorded workplace applied related training OR 3 years on same aircraft type
Have attained Specialist Level 2 NDI qualification (e.g. EN4179, ASNT, PCN) in at least 4 methods (PT, MT, ET and UT)
Holds 2nd signature
Equipment specific training and relevant type training (‘Q’ Course) if required
Leadership skills and proven ability to supervise all levels of engineering personnel
Demonstrate knowledge / understanding of aircraft maintenance and engineering
Must have completed a recognised aircraft engineering apprenticeship in industry/military or similar qualification in aircraft systems
Must Have Specialist Level 2 NDI qualification (e.g. EN4179, ASNT, PCN) in at least 4 methods (PT, MT, ET and UT)
Must have experience working knowledge of EASA Part 145
High level of interpersonal skill to co-ordinate a number of activities and the ability to communicate, influence and direct decision-making

Job Responsibility

To undertake scheduled and unscheduled maintenance activities of Non Destructive Inspection in support of Typhoon operations and in accordance with the RSAF Typhoon maintenance policy, ensuring that all Continuing Airworthiness and Maintenance activities are carried out in accordance with Saudi Arabia SALAM Maintenance Organisation Exposition and associated Quality Management System
Undertaking all NDI activities within the scope of the NDI test regime
Deputising for the NDI Lead when required to do so
Managing the available manpower by coordinating with his Specialist Supervisors to ensure aircraft generation
Submission of TQs and TPRF including the embodiment of all Technical Instructions and Modifications
Ensure that all electronic data systems are utilized correctly within process and adhere to operating procedures
That Depth Management & Customers reporting is readily available
Support the NDI Lead in the management of the facilities ensuring that damage or defects to equipment or buildings is reported promptly to the correct organizations and followed through to a full conclusion
Ensuring that all personnel engaged in activities in areas under his control follow the correct engineering practices, observe safety precautions and that as far as is reasonably practicable no one is exposed to any unnecessary or uncontrolled risks
Ensure shift handovers are carried out without ambiguity and that daily diaries are maintained

What we offer

Shared accommodation & flights

Software Development Senior Specialist

Develop, test, and maintain software applications and systems. Write clean, effi...

Location

India , Bangalore

Salary:

Not provided

NTT DATA

Expiration Date

Until further notice

Requirements

Must have excellent working experience on Core Java, microservices
Must have good working Experience on Rest APIs, Spring boot, JPA/Hibernate, Kafka/JMS, Kubernetes
Must have good working Experience on SQL/No SQL, Mongo DB
Must have good working knowledge on any of the lifecycle management tools like JIRA, Git, GitHub/ Bitbucket, Eclipse/ IntelliJ IDE
Working knowledge in at least one of the Cloud - AWS/ Azure
Experience in leveraging Continuous Deployment / Continuous Integration (CI / CD) pipeline for different platforms
Good understanding of OpenShift or PCF

Job Responsibility

Develop, test, and maintain software applications and systems
Write clean, efficient code using Java & Spring boot
Collaborating with QA Analysts and Software Developers to develop solutions
Work along with larger scrum team to delivery assigned stories within scheduled time, maintaining the coding standards, Quality and code efficiency
Document the framework for change implementation and integration requirements

Fulltime

Specialist QA - Major Deviations

Let’s do this. Let’s change the world! In this vital role, you will serve as a Q...

Location

United States , Juncos

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree OR Master's degree and 2 years of Manufacturing Support and/or Quality Assurance experience OR Bachelor's degree and 4 years of Manufacturing Support and/or Quality Assurance experience OR Associate's degree and 8 years of Manufacturing Support and/or Quality Assurance experience OR High school diploma / GED and 10 years of Manufacturing Support and/or Quality Assurance experience

Job Responsibility

Provide Quality oversight to ensure clinical and commercial pharmaceutical products are manufactured, tested, stored, and distributed in compliance with cGMP and applicable regulations
Serve as Quality investigation lead and decision-maker for complex Major Deviations, maintaining accountability for investigation quality, timelines, documentation, and closure
Actively participate in deviation and RCA meetings, managing multiple concurrent deviations and driving effective resolution
Conduct thorough root cause investigations, including floor presence, process observation, and personnel interviews across shifts, including nights when required
Review, approve, and track cGMP documentation, including Deviations, CAPAs, CAPA Effectiveness Verification (EV), Change Controls, validations, and associated records
Demonstrate strong critical thinking skills, the ability to distinguish causal factors from root causes, and the ability to evaluate investigation quality using evidence-based decision making
Ensure that changes with potential impact to product quality are properly assessed and documented per established procedures
Verify that deviations from established procedures are investigated, documented, and resolved in accordance with Quality System requirements
Ensure production records, laboratory results, and investigation documentation are complete, accurate, and compliant with cGMP standards
Collaborate cross‑functionally with Manufacturing, Engineering, Validation, and Quality to implement effective and sustainable CAPAs

What we offer

Health and welfare plans for staff and eligible dependents
Financial plans with opportunities to save towards retirement or other goals
Work/life balance
Career development opportunities
Retirement and Savings Plan with generous company contributions
Group medical, dental & vision coverage
Life & disability insurance
Discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans and an annual site shutdown

Fulltime

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Senior QA Specialist

Job Description

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