Pharmaceutical Quality Analyst

Uniting Holding; Waterford; On-site; EUR 42,000 - 62,000; Full time

Benefits offered by this job

Weekly pay

21 days annual leave

Bank holidays off

Travel expenses paid for work trips

Training and career progression

Employee Assistance Programme (EAP)

Discretionary Christmas Perx bonus

Job summary

Store-All in Belview, Waterford, is hiring a Pharmaceutical Quality Analyst to join the Quality team. The role is based at Marine Point, Belview, Waterford, and reports to the Quality Manager. You will ensure GDP, GMP, ISO standards, BRC and HACCP compliance across operations.

You will train staff, perform QA inspections, and support audits with customers and regulators. This is a full-time position with responsibilities spanning quality, safety, and document control.

Qualifications

• Aptitude for SOPs/WIs documentation and control.
• Experience with quality systems in Food/Pharma.
• Auditing experience with regulatory audits (customer/regulatory).

Responsibilities

• Maintain Temperature Monitoring System and QC programs.
• Lead quality audits and supplier/provider approvals.
• Deliver training on Store-All procedures and SOPs.
• Prepare Annual Review for continuous improvement and support internal audits.
• Coordinate with Regulatory/HPRA audits and customer audits.

Skills

Auditing

Training

SOPs/WIs

Tools

MS Office

QMS/ISO Standards

Job description

Pharmaceutical Quality Analyst- Store-All Logistics

CompanyBackground

Store-All is one ofIreland’slargest supply chain management companies. The company currently managesin excess of850,000 sq ft of warehousingacross16 locationsacross 8 sitesin the South-Eastand has its HQ nearBelviewPort.The company offerscustom and integrated (Transport & Storage)supply chainsolutionsforsome of theworld’sleading Food & Pharma multinationals.The company alsoprovidesDocument & Self-Storageservices.Further sites are being developed to supportbusinessexpansion.

Reason for Vacancy

The company hasrecently beenbought out by two managerswhohave ambitious plans todevelop the business.There is currently a requirement for aQuality Analystwho will workwith theQuality Teamreporting tothe QualityManager.You will be part of the Quality team that interacts with customers, suppliers, and internally withStore-Allemployees.This role is afull-timerole based at Marine Point in Belview, Waterford.

A Day in the Life of ourQuality Analyst

As Store-All Quality Analyst you are expected to work in tandem with the RP/Quality Manager to ensure that:

• TheStore-All Quality System consistently meets current GDP, GMP, ISO 9001:2015, ISO 45001:2018, BRC, HACCP & customer requirements.
• The Store-All Quality System is updated andmaintainedon an on-going basis.
• Allaspects of Store-All’s operations are covered by the Quality System.
• Allpersonnel are trained consistentlyinall relevant aspects of the Store-All Quality System.
• You will be part of the Quality team that interacts with customers, suppliers, and internally with Store-All warehouse staff.
• As Store-All Quality Analyst, you are required to set a good example to all personnel, whilst also communicating the importance of meetingcustomers, as well as statutory and regulatory requirements.
• Youare also required todeliver internal training to personnel when required.

Key Responsibilities

Quality

• Monitoring and maintenance of Temperature Monitoring System.
• Implementation,monitoringand maintenance of Quality Systems.
• Liaise with RP & Quality Managerwith regard toQuality Issues.
• Adhering to KPIs.
• Attending Quality meetings.
• Liaising with theResponsible PersononQuality & GDP related training.
• Dealing with customer queries & complaints.
• Performance of QA Inspections.
• Assistancein compilation of Annual Review for Continuous Improvement
• Performance of and involvement in Internal Audits.
• Involvement in Customer/HPRA, ISO and BRC audits.
• Approval of customers and service providers, and creation of Technical Agreements.
• Monthly review and update of schedules/controlled lists.

Training

• Maintenance & update of training database
• Training of employeesonStore-All procedures.
• Delivering Practical and SOP Training to Store-All personnel.
• Delivering Refresher Training to Store-All personnel, whenrequired

Health & Safety

• Be aware of Health & Safety compliance, and the risks which are associated with warehouse and yard activities. High visibility vest, safety shoes and company ID badgemust beworn when you are on the warehouse floor. Smoking isstrictly prohibitedin our warehouses, offices & canteens.
• Adhere to safety requirements, as outlined in our procedures and Safety Statement
• Maintain controlled access to security sensitive information, asrequired.
• Youare required tofollow Store-All Health & Safetypolicies andinform superiors of any safety issues identified/observed.
• Responsibility and authority for ensuring the health and safety management system conforms to the requirements of ISO 45001 and for reporting on its performance to senior management.
• Review supplier risk assessments and method statements (RAMS) prior toworkbeing carried out.
• Drive and implement any safety related changes that aredeemednecessary.
• Review all safety related change controls.
• Evaluate internal and external safety trainingprogrammescarried out throughout the year.
• Liaise with warehouse safety representative on safety matters and coordinate safety meetings, whendeemedappropriate.

Reporting

• Maintaining Logs for Investigation Reports,Safety Incidents,Change Control Forms & Destruction Dockets.
• Maintaining Indices and trackers for SOPs & Controlled Lists.

• Raising & review of Investigation Reports.
• Follow up & close out of Investigation Reports.
• Bi-annual review of logs as per CL016.
• Comply withreporting proceduresin a timely manner.

Compliance

• Youare required toalways adhere to Store-All SOPs and policies.
• Inspection and auditing on a routine basis to verify compliance with company standards for operational and general maintenance.
• Writing and updating of company SOPs, Forms, WIs Controlled Lists & Quality Documentation.
• Issue and sign off on Change Control Forms.
• Follow up & close out of Change Control Forms.
• Comply withGDP, GMP, Quality and HACCP requirements, as per Store-All SOPs and policies.
• Ensure that ISO9001, ISO45001, BRC, HACCP, GDP standards and customer requirements arealways metand up to date systems and forms are being used.
• Adhere to all company policies,proceduresand business ethics codes, and ensure that they are communicated and implemented within the company.
• Total confidentiality must bemaintainedin all areas in relation to Store-All client information. No discussion with any client, supplier or third party in relation to another client orsupplier’scontents or information is allowed.Ensure background checks and identification checks are completed in line with internal procedure andin a timely mannerprior to staff getting unescorted access to air cargo or sensitive information.

Experience

• Aptitude for writing SOPs/WIs.
• Background in Quality with Food/ Pharmaceutical Company.
• Intermediate Computer Skills.
• Familiarity with ISO 9001:2015 standard.
• Familiarity with ISO 45001:2018 standard.
• Familiarity with HACCP requirements.
• Familiarly with BRC.
• Train the Trainer’ Certificate.(Desirable but not essential)
• Auditing Skills.
• Experienced in External (customer/regulatory) Audits frompreviousemployment.
• Training on all Store-All SOPs, where applicable.

Benefits

• Salary DOE (Depending on Experience)
• Weekly pay
• 21 days’ paid annual leave
• Bank holidays off
• Full travel expenses paid for work-related trips
• Training and career progression opportunities
• Employee Assistance Programme (EAP)
• Discretionary Christmas Perx bonus

Essential Requirements

• Applicants must have the legal right to work in Ireland. Store-All is unable to provide employment permit sponsorship for this position.
• A full, clean driving licence is required.
• Access to your own transport is essential to ensure reliable travel to and from work.