QA Regulatory Compliance Specialist Job at PCI Pharma Services (Stamullen)

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

Qa specialist

Responsible for executing the food safety and quality strategy for the Specialty...

Location

Netherlands , Amsterdam

Salary:

Not provided

ADM

Expiration Date

Until further notice

Requirements

Bachelor's degree in food technology, Quality Management, or related field
3+ years of experience in quality management in the food industry
Strong knowledge of food safety standards and quality systems (HACCP, GMP, QMS)
Experience with supplier quality and auditing processes
Skilled in process improvement and root cause problem-solving methodologies
Excellent communication skills with the ability to work collaboratively across departments
Proactive, solution-oriented, and able to prioritize multiple tasks in a dynamic environment
Fluent in English
Dutch proficiency preferred

Job Responsibility

Ensure food safety and quality compliance for products distributed in EMEA, aligned with ADM policies, regulatory requirements, and customer standards
Collaborate closely with factory Quality Managers and Technical Support teams globally (EU, USA, India, Serbia) to optimize quality across the supply chain
Provide proactive support and consultation to management on quality issues, regulatory compliance, and food safety improvements
Conduct and coordinate internal and external audits
host auditors from customers, certification bodies, and governmental agencies
Train internal teams on food safety, GMP, and quality principles to ensure compliance awareness
Maintain and update quality documentation, including product specifications and Certificates of Analysis (CoA)
Manage returned goods workflows, including review, disposition, and corrective actions
Support supplier and co-packer qualification, maintaining approval of documentation and performance records
Manage product certifications such as Kosher, Halal, and Non-GMO

Regulatory Affairs Specialist

An excellent opportunity to join a leading global food business based in central...

Location

United Kingdom , London

Salary:

45000.00 - 50000.00 GBP / Year

The People Co.

Expiration Date

Until further notice

Requirements

5+ years of technical or regulatory experience in food, feed or ingredients
Highly analytical, and organised with keen attention to
Must be able to identify problems and provide systematic
Be able to multi-task and have excellent communication skills
Real team player – Must be able to work with senior and junior employees in a professional and inclusive manner
A high level of business English is essential
The successful candidate will be self-motivated
Strong administration skills on Microsoft Office Packaging on Windows

Job Responsibility

Ensure regulatory compliance with food and feed safety, quality and defence as it relates to UK, EU and GFSI (BRC) requirements, Organic, Halal, FAMI QS and Kosher
Monitor changes in legislation and regulatory requirements, proactively assessing the impact on business and updating the senior management team's compliance protocols as necessary
Support the development and implementation of regulatory strategies for existing ingredients and new ingredients/products in the UK and EU regions ensuring compliance to but not limited to Allergens, REACH, Novel food, Packaging Food Contact Materials, Food Law and labelling, Feed laws and labelling, Residues and Contaminants, Natural and Botanical ingredients etc
Provide regulatory review of product compliance when an in-depth analysis/review is needed for the quality department. Example of review provided: Novel food status, specific application status, claims, labelling
Coordinate with authorities for all work required, such as authorisation and licenses
Support the design and maintenance of Prinova Specification, ensure all information is correct and meets relevant EU regulation requirements
Provide training for the quality and technical teams in Europe
Actively support QA department tasks according to workload and priorities, as required
Provide support to the commercial and marketing team to verify regulatory compliance
Assisting, as required, in the management of crises and incidents as part of the management team

Senior QA Specialist

The incumbent is a member of the Quality Assurance (QA) Operations team. Under t...

Location

Singapore , Tuas

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Degree in Chemistry, Microbiology, Engineering or other Science related discipline
Minimum 4 years experience (including QA roles) within the pharmaceutical industry
Compliance, regulatory or validation experience is an advantage
Strong written and oral communication skills
Technical report writing skills is an advantage
Demonstrated personal leadership, accountability, and organizational skills with proven ability to operate independently with minimal supervision
Experience working in a cross-functional, matrix environment is an advantage

Job Responsibility

Provide QA oversight to site operations (primarily Production, Quality Control, Warehouse, Engineering) to ensure products produced are in compliance with Pfizer Quality Standards (PQS) and ICH guidelines
Work with supply chain and downstream / drug product sites to ensure timely delivery of quality products
Support regulatory team to file products and address regulatory queries in an accurate and timely manner
Understand regulatory expectations and support site inspection readiness
Drive quality culture and promote GMP compliant behaviors at the site
Drive improvement of quality systems in collaboration with cross functional teams
Contribute to achieve our vision of being best in class manufacturing site, producing highest quality products in the safest way
Deploy and use Imex 'way of working' for day-to-day operations, problem solving, escalation and continuous improvements
Mentor members within the QA team

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

IT Quality-Specialist

Join Amgen’s Mission of Serving Patients. In this vital role you will lead the e...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree with a minimum of 7 years experience in Software and Systems Quality assurance
Bachelor’s degree with a minimum of 10 years of Software and Systems Quality assurance experience
Strong understanding of the regulations outlined in 21 CFR Part 11, EU Annex 11, GAMP standards
Proven experience in the validation of computerized systems (GxP)
Strong understanding and application of GxP regulations (GMP, GLP, GCP, GPvP, GDP)
Experience managing quality assurance processes, including Major and Minor Deviations
Demonstrated ability to handle and resolve complex quality issues using analytical and problem-solving skills
Strong decision-making abilities with the capacity to drive tasks to completion
Ability to work independently with minimal supervision
Leadership skills with experience leading projects, teams, or tasks

Job Responsibility

Lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures
Supervise validation activities through internal audits and conduct risk assessments to identify the need for requalification and establish policies for computer system re-validation
Actively participate during all phases of qualification/validation of computerized systems: evaluate projects
provide guidance and technical information to others (lead qualification/validation activities)
determine and establish requirements for qualification/validation of each individual system/equipment
formulate independent decisions related to qualification/verification activities
Review validation/qualification packages of computerized systems for completeness and accuracy, sound rationale, Regulatory expectations, compliance with validation policies and procedures, and accurate data analysis
Serve as Owner or QA Contact for Minor and Major Deviations
Compare results against acceptance criteria and work with appropriate departments to resolve exceptions and deviations
Bring critical exceptions or deviations to management’s attention and initiate and enforce necessary improvements and corrections to established systems and processes

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

New

QA Raw Material Compliance Specialist

Be the gatekeeper of quality-safeguard raw material compliance in a dynamic GMP ...

Location

Switzerland , Visp

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Degree in Life Sciences, Pharmacy, Chemistry, or a related field
Familiarity with GMP regulations and change control processes
Detail-oriented, organized, and capable of managing multiple priorities
Strong communication and teamwork skills, both written and verbal
Ability to work independently and collaboratively within a team
Experience with supply chains, raw materials, equipment, facilities, and logistics is advantageous
Proficiency in English
German language skills are a plus

Job Responsibility

Review, assess, and coordinate the evaluation of Vendor Change Notifications (VCNs) from suppliers
Conduct and document impact assessments in collaboration with relevant departments
Track and manage VCNs to ensure compliance with internal procedures and regulatory standards
Oversee the timely implementation of required actions and updates to documentation
Work within systems such as SAP, TrackWise, and Document Management Systems to maintain accurate records

Senior QA/RA Specialist

The primary role of Quality Assurance function is to ensure that management syst...

Location

United Kingdom; Ireland , Harrogate; Dublin

Salary:

Not provided

ResMed

Expiration Date

Until further notice

Requirements

Bachelor's degree (technical or software background preferred) from four year college or university
at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices
four (4) to five (5) years related experience or equivalent education and experience
Strong experience or exposure across Quality Systems (ISO 13485) / Design and Development of Medical device software (IEC 62304 environment)/ Supplier quality / Medical Device Regulation (MDR 2017/745)
Good Knowledge of ISO 13485 standard and Medical Device Regulation (MDR 2017/745)
Ability to exercise judgment
Good communication, planning and organizational skills
Proactive
able to provide initiative, ownership while working through uncertainty
Self-starter, with the ability to work with minimal supervision and with a sense of urgency

Job Responsibility

Role of Management Representative (ISO 13485)
Ensure the processes needed for the Quality Management System are effectively defined, documented, implemented and maintained
communicate and report on the performance and effectiveness of the QMS and any need for improvement to the senior management team and all other company personnel
Ensure the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization
Coordinate and execute to support QMS activities
Ensure complaint handling / investigations, CAPA, Nonconformities, are processed and resolved in a timely manner
Suppliers’ management (including evaluation, monitoring, quality agreements)
Design and Development activities
Change control
Internal / external / supplier audits

What we offer

All employees benefit from a bonus plan
Working from home flexibility
Access to a referral bonus
Access to ResMed's preferred shareholding programme
Internal career opportunity

Fulltime

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QA Regulatory Compliance Specialist

Job Description

Job Responsibility

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