Title

Qualified Person

Qualified Person

Qualified Person
A growing multi pharmaceutical company based in Co Waterford are recruiting a Qualified Person to join their busy quality team. Reporting to the Head of Quality on site, the Qualified person will act in accordance with Annex 16, EudraLex, Volume 4 and directive 2001/83/EC to support disposition of company products.
Key areas of responsibility:
  • Manages the batch disposition process to ensure timely release of products.
  • Ensures the batch disposition process maintains compliance with site practices & regulatory requirements.
  • Disposition of products and materials in accordance with directive 2001/83/EC and Annex 16, EudraLex, Volume 4, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use.
  • Support major investigations, ensuring all product deviations are closed prior to batch release.
  • Reviews and approves Product Quality Reviews.
  • Reviews and approves new and revised master manufacturing records.
  • Participates in cross-functional teams as Quality/Qualified Person representative.
  • Participate in third party/supplier audits, as required.
  • Review annual customer complaints.
  • Participation in any product recall or product defects.
  • Actively contribute to continuous improvement initiatives.
  • Conduct duties in a safe manner and report all safety issues and concerns.
  • Complete all duties as per relevant SOP’s.
  • Review of investigation reports.
  • Review of validation protocols.
  • Review of Quality Documentation as appropriate e.g. Bill of Materials etc.
  • Work with relevant departments to ensure timely closure of Quality Actions / Findings.
  • Provide additional QP support to quality related issues, as required
The ideal candidate will:-
  • Must meet the minimum training/education requirements for QP qualification
  • Must have at least 5-7 years’ experience working within a Quality Assurance role
  • Work experience acting as Qualified Person, named on a Manufacturing and Importation Authorisation (MIA) is highly desirable.
  • Finished dosage formulation manufacturing experience is a requirement for the role
  • Outstanding organisational and time-management skills.
  • Ability to leverage/collaborate effectively with internal and external stakeholders
  • Excellent written and verbal communication and interpersonal skills.
  • Strong problem-solver.
  • Resourceful.
  • Independent, critical thinker with strong decision-making skills.
  • Comfortable working in a busy, fast paced regulated manufacturing environment

Site Manager

Site Manager

Our client a long established leading construction company has an excellent new opportunity for a Site Manager. Based in Tipperary, reporting to the Contracts Manager, the overall purpose of this role is to take responsibility for leading the construction team and subcontractors on a construction site in line with all customer requirements and in a safety conscious environment
Key responsibilities will be as follows:-
  • Coordination of subcontractors, control programme with preparation of forward planning programmes to facilitate the successful completion of the works on time.
  • Ensure each projects are completed to programme, on budget and to an extremely high standard in compliance and quality
  • Work with Management and Clients to define and implement strategic and tactical plans and concepts in order to effectively prioritize daily tasks procedures.
  • Take full responsibility for Health & Safety on site to ensure the site is maintained as a Safe site and all training and guidelines are completed
  • In line with the H&S Officer, review and approval of method statements and risk assessments
  • Ensure safety of general public at all times
  • Ensure that appointed sub-contractors are fully briefed on all the company’s systems and procedures
  • Supervise the daily activities of direct reports, providing feedback, performance management, conflict resolution and support.
  • Responsible to ensuring all staff receive all required training and follow SOP guidelines
  • Preparation of weekly and monthly progress reports on site activities
Requirements
  • Ideally you will have a Degree in Construction Management or a Trade Qualification.
  • 5+ years' experience residential or commercial construction at a manager level.
  • Possess strong planning, organisational and teamwork skills.
  • Excellent communication and presentation skills.
  • Have a high level of competency and accuracy in writing and maintaining clear and professional documentation
  • Proficient with Microsoft Office Products
  • Have the ability to build strong relationships with clients, staff and sub-contractors
Generous annual salary per annum with company vehicle/fuel card/pension/performance bonus.

Automation Engineer

Automation Engineer

Automation Engineer
Excellent new role for an Automation Engineer for a new pharmaceutical startup operation based in Waterford City. The overall purpose of this role is
  • To provide Automation and Equipment engineering support to site systems and process equipment and to ensure they are operated, improved and maintained to meet Customer and compliance requirements.
Responsibilities will include:-
Automation systems
  • Facilitate internal resources and outside vendors in developing technical solutions for automated equipment. Interface with equipment vendors to ensure successful equipment delivery, integration and validation.
  • Maintain PLC automation systems in a validated state in compliance with site change control.
  • Understand the requirements of computer systems validation and ensure compliance is maintained.
  • Act as operations support for Fill Finish and Oral Dose facilities.
  • Interface with Operations, IT, QS and QA groups to successfully validate software systems and adherence to life cycle management and system maintenance
  • Provide automation requirements and implement solutions for new products and/or capacity expansions
  • Support disaster recovery and back up procedures and processes to ensure business impact is minimized in the event of a failure.
  • Provide technical and automation core competency support, including possible off-hours, remote and onsite coverage. This also includes operations / engineering training on basic troubleshooting
  • Management of Automation vendors during equipment troubleshooting and upgrade activities
Health, Safety and the Environment
  • Comply at all times with the Health, Safety and Environmental policy and associated procedures.
  • Continuously promote a positive safety culture by challenging yourself and others to prioritise safety in everything you do.
Quality Compliance
  • Ensure all work carried out, is in compliance with the required standards, conforming to company, cGMP, cGLP, SOP’s and regulatory guidelines
  • Take ownership for quality compliance in all activities you are responsible for
The ideal candidate will have:
  • Engineering degree in Electronics, Electro-mechanical or equivalent training/experience
  • Minimum of 5 year’s engineering experience within Pharma Industry.
  • Experience with Siemens S7 PLCs and WinCC flexible desirable.
  • Experience with Fill Finish equipment required.
  • Experience working in a cGMP/FDA/HPRA regulated environment.
  • Experience with Industrial Ethernet and Scada systems

Site Engineer

Site Engineer

Our client, a long established leading South East Construction company has an excellent new opportunity for a Site Engineer. Based in Waterford, reporting to the Site Manager, the overall purpose of this role is to ensure all the site engineering requirements are met to a high standard in a timely fashion.
Requirements for the role
  • The ideal candidate should be degree qualified in engineering
  • A minimum of 5 years' experience in setting out or site engineer
  • Experience working with a main contractor, subcontractor, surveying firm or similar preferred
  • Good understanding of Health, Safety and Environmental regulations
  • Excellent communication skills
  • Working knowledge in Microsoft Office, Project, PowerPoint etc.
  • Experience in setting out, groundworks, concrete and steel structures and preferably RC experience.
  • You can expect to work on Commercial and Residential projects

Excellent career progression

Receptionist/Front of House

Receptionist/Front of House

Receptionist /Front of House Administrator
Our client, a leading service provider in their field based in Waterford City are looking to recruit an experienced Front of House/Receptionist Administrator.
The overall Purpose of this busy role is to ensure each and every client experiences a high level of customer service, ensuring the reception area is run with a high level of efficiency and organisation and all day-to-day administration is completed.
The ideal person will take ownership of this role, engage in a range of duties and responsibilities to support the busy team
  • Meeting and greeting clients
  • Scheduling of appointments
  • Manage a busy switchboard
  • Tying, formatting and compiling of letters
  • Handling incoming and outgoing post and couriers
  • Handling cash, card and cheque payments
  • Adhering to GDPR confidentiality
  • Any other duties reasonably requested
  • Other ad-hoc tasks as they arise
Skills / Qualifications
  • Candidates must have a 3rd level qualification in administration
  • A min of 3 years’ experience in a Front of House/Reception role
  • Experience using Apple Mac an advantage
  • Experienced in the use of a diary management systems, word and other packages.
  • The candidate should be a personable individual with a proven track record of excellent organisation skills and strong attention to detail
  • Must be highly professional and well presented at all times
  • An strong ability to multitask in a people facing environment

 
RPG Cookie Policy

This website uses cookies that are necessary to its functioning and required to achieve the purposes illustrated in the privacy policy. By accepting this OR scrolling this page OR continuing to browse, you agree to our privacy policy.