• Check and audit all process documentation to ensure this is completed correctly and in accordance with site quality procedures.
• Audit and record findings of inspections and report any non-conformances.
• Ensure that any corrective actions are followed up and closed out.
• Report all necessary matters to the Quality Assurance Supervisor,
• Ensuring that he/she is fully aware of relevant production, personnel, quality and OV issues.
• Ensure microbiological testing, water testing and nutritional testing is carried out as routine.
• Help ensure staff adhere to stated hygiene and personal hygiene policies.
• Audit critical control parameters within the factory processes.
• Carry out and assess incoming ingredients, raw materials, factory trials and finished products, to check in line with customer requirements before release to factory or customer.
• Check quality and adherence to specification of finished products
• Assist in preparation of, and compliance during customer visits and audits within the factory.
• Ensure all product adheres to specifications on product quality, labeling etc,... 
• Checking label books and auditing these against factory intakes for mass balance purposes.

Skills: Process Documentation Management, Inspection and Reporting, Corrective Action Implementation, Communication Skills, Quality Testing, Hygiene Compliance, Critical Control Parameter Audit, Quality Assurance and Compliance

• Plan and conduct assigned audits
• Assess compliance with Quality management systems
• Maintain up to date knowledge of regulations, guidelines and the company’s SOPs
• Plan and conduct follow up of audits of high-risk suppliers
• Plan and produce audit plans and detail scope of the audit
• Plan audit of review in comparison to previous audit reports and relevant up to date legislation
• Conduct allocated system, process, facility, study, document and data audits by review of relevant documentation as well as attention to detail on relevant procedures and tours
• Present audit findings to colleagues
• Conduct peer reviews of colleague’s audit reports to ensure accuracy and appropriateness of findings and classification of findings.
• Conduct QA review of SOPs and associated Master Forms as part of review and approval system within QuMas
• Plan, conduct and follow up audits across all business areas within hVIVO and all audit types and document types (laboratories, clinical, data management, computer system validation)
• Plan, conduct and follow up allocated remote (questionnaire and due diligence) audits
• Compile relevant questions to assess compliance of service being provided
• Assess information provided or sourced to provide decision on suitability of supplier or subcontractor to provide services to the company and add to QA approved suppliers list

Skills: Audit Planning and Execution, Quality Management Systems (QMS) Compliance, Regulatory Knowledge, Supplier Auditing, Audit Documentation, Legislative Compliance, Attention to Detail, Communication Skills

• Conduct audits on-going studies, systems and documents to assure quality assurance compliance with regard to ICH/FDA GCP, SOPs, and national/local guidelines.
• Routinely provide GCP/QA consultation for all Company staff.
• Ensure the timely and effective follow-up of all identified or assigned quality issues.
• Manage CAPAs from audits and non-audit sources.
• Develop and maintain Study Audit Plans and to act as a QA Representative for projects allocated by QA Management.
• Assist in the review of Pharm-Olam SOPs.
• Assist in Sponsor audits/Inspections at sites and at Pharm-Olam offices.
• Keep up-to-date with relevant guidelines and to assist with internal training, on a regular basis.
• Assist with the training of operational staff.
• Deliver on other related duties or responsibilities by the line manager.
• Reporting to a Principal Quality Assurance Auditor/Manager, Quality Assurance.
• Plan, conduct and follow up onsite audits in line with the supplier audit plan
• Act as Lead Auditor to plan, conduct and follow up on-site audits of suppliers and subcontractors in line with the supplier audit plan
• Liaise with relevant hVIVO staff requesting use of the supplier or subcontractor to ascertain scope of the audit required.

Skills: Quality Assurance Compliance, GCP/QA Consultation, Issue Management, Audit Planning and Execution, SOP Review and Development, Auditor Training, Sponsor Audits/Inspections, Supplier Audit Management

• Works with QA team to plan, conduct and complete written reports for each audit assigned.
• Monitors the projects and audit status in assigned areas and provides QA Management with current status upon request.
• Fosters a good working relationship with internal clients and QA team.
• Identifies areas for process improvement and provides this information to management.
• Assists with corrective and preventive action plans (CAPAs) to assure follow-up and implementation of corrections for internal and external audits.
• Provides advice and guidance on regulatory requirements and SOPs.
• Assists with training and mentoring of less experienced auditors.
• Oversees the maintenance of records for each audit.
• Assists with creating and presenting GCP/GLP and other related training sessions.
• Propose recommendations and perform data analysis.
• Accompany the external auditor through the execution of audit
• Inform and coordinate with internal stakeholders the audit mandate, agenda, interviews and audit execution
• Accompany the functional auditor through his SOJT and act as a mentor.
• Assess the functional auditor for his final approval and made final recommendation to Quality Assurance Management.
• Act as a mentor in regards of the Quality Assurance Internal Audit Program

Skills: Audit Planning and Reporting, Project Management, Relationship Building, Process Improvement, Regulatory Compliance, Training and Mentoring, Record Management, Data Analysis and Presentation

• Completing Audits linked to the QA program through Moderation of audits, thematic, monthly, dip sample audits
• Contributing to the production of reports to timescale relating to the work undertaken by the QA activity.
• Audit training and feedback to auditors about the quality of audits produced
• Sharing the findings from audits with operational service to improve practice
• Identification of good practice examples such as direct work with children, assessments and plans.
• Embedding the Practice Framework Model within operational services.
• Being a good practice enabler lifting practice across the service in line with the service, organizational plans and OFSTED priorities.
• Control CCP consumables such as metal detector pieces, scales, probes etc.
• Oversee pre-production checks, ensuring all areas are covered.
• Check line integrity at start of shift by means of hygiene swabbing and audit of the hygiene process.
• Carry out GMP audits, following up any non-conformances and actions required with the necessary teams, reporting any issues that cannot be resolved at the time.
• Complete background checks on equipment and factory environment to ensure that all comply with requirements, are in good working order and fit for purpose.

Skills: Audit Management, Report Writing, Training and Feedback, Stakeholder Communication, Identification of Good Practice, Implementation of Frameworks, Quality Assurance Compliance, Problem-solving and Follow-up

• Understanding and applying FDA’s Quality System Regulation and ISO 9001 and 13485 requirements for quality management systems, including leading and supporting Audit program.
• Ability to use tools to uncover root causes and implement corrective actions.
• Proficient in basic information technology tools including MS Word, Excel, and PowerPoint.
• Effective written and verbal communication skills across all levels of the organization.
• Must be an effective communicator, and able to deliver messages through presentations, written and verbal communication.
• Knowledge of LEAN, Six Sigma and statistical process control.
• Must be action-oriented, customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, and analytical thinking.
• Requires moderate direction to complete more complex tasks, completes routine tasks with little or no supervision.
• Ability to handle multiple tasks concurrently and in a timely fashion.
• Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.
• Must display eagerness to learn and continuously improve.
• Positive work attitude that supports teamwork and continuous improvement

Qualifications: BA in Chemical Engineering with 4 years of experience.

• QA experience and a working knowledge of cell culture and aseptic processing experience required.
• Experience performing internal audits and third party audit management required.
• Experience with oversight of aseptic processing and the associated international.
• Aseptic processing regulations and medical device regulations.
• Working Knowledge of endotoxin testing required.
• Experience in a Quality Assurance function / GxP quality assurance auditing in Clinical Research/ Pharma/CRO
• Experience in working in the clinical, regulatory, pharmacovigilance, or quality environment within CRO/ pharmaceutical / healthcare environment
• Robust experience in GCP, additional experience in other GxP areas, preferred (e.g. GLP, GVP, GMP, GDP )
• Computer Systems Validation (CSV) experience, preferred
• Excellent verbal and written communication skills
• Excellent interpersonal skills and organizational skills
• Read, write and speak fluent English, fluent in host country language required

Qualifications: BS in Industrial Engineering with 3 years of experience.

• Experience required as a Quality Auditor in a regulated pharmaceutical environment
• Uses best practices and knowledge of internal or external business issues to improve products/services or processes
• Typically resolves complex problems or problems where precedent may not exist, takes a new perspective using existing solutions
• Participates in project teams
• Acts as a resource for colleagues with less experience
• Requires in-depth knowledge and experience of audit management and execution
• Works independently, receives minimal guidance
• Strong working knowledge of current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), the rules governing medicinal products in the European Union, WHO and other regulatory requirements
• Experience preparing technical/complex written materials that are accurate, clear, logical, well-organized and grammatically sound

Qualifications: BA in Biochemistry with 2 years of experience.

• Experience with software development processes
• Familiar with industry quality standards, such as ISO, DO, or SPICE
• Experience with performing internal process audits and process improvement work
• Exceptional communication skills including clear and concise writing, an engaging presentation style, and group facilitation
• Strong teamwork skills with a demonstrated ability to collaborate across teams and roles
• A thorough knowledge of ICH GCP and relevant European Directives/FDA guidelines and other national guidelines/regulations.
• Excellent communication and interpersonal skills.
• Ability to perform on average up to 18 audits annually, lasting 1 or more days
• Up-to-date passport and attention to detail.
• Ability to work independently and to succeed in a fast-paced environment
• RQAP Certified highly desired
• Self-motivated with the ability to work in a team

Qualifications: BS in Information Systems with 5 years of experience.

• Experience auditing reports under 40 CFR 160
• Knowledge of Good Laboratory Practices and some years of professional experience
• Knowledge of plant protection product data development and analytics
• Previous experience as a Quality Assurance Auditor or equivalent strongly preferred
• Experience in agriculture or regulatory science strongly preferred
• Experience in Good Laboratory Practices and/or a regulated industry preferred
• Experience in an agriculture biology laboratory including pesticides and/or seeds and traits, and/or crop products
• Experience with bio-analytical instruments and data
• Demonstrated excellent attention to detail, organizational skills, and ability to prioritize work
• Strong communication skills, both verbal and written

Qualifications: BA in Mathematics with 4 years of experience.