PHARMA SERVICES is looking for employees for positions:
compliance manager
Trade
education & Instruction
Education & Instruction
Requirements
understanding of Competency/Compliance process
assessment qualification
continuous Improvement Qualification
comfortable to train groups/individuals
degree or equivalent Training and Management qualifications
Responsibility
management of relevant Policies, SOP’s and work instruction relating to staff training are complete and up to date
ensure that staff are trained in cGMP and knowledge updated as required
work with the business to develop the competencies necessary for On-the-Job Training
provide technical expertise for client and regulatory audits
work with Internal partners to develop the current portfolio of training courses on the E Learning Platform
ensure that identified Trainers and SMEs are correctly trained to deliver and assess staff for all practical applications
work with managers to address learning issues, instructional problems or new additional educational needs relating to product, quality or deviations
oversee that documented evidence for staff training and assessed competence exists and is available for audit scrutiny
material planner
Trade
administrative Assistance
Administrative Assistance
Responsibility
responsible for management of routine artwork / material changes
creation / amendment of master batch records to support rework, artwork / item code changes & non-technical update
chair regular planning meetings ensuring effective communication and feedback between Operations and support services
prepare regular reports for support of performance measures highlighting any future shortfalls or opportunities within a timely manner to Senior Management team
to comply with all Company Policies and Management instructions relating to internal and external Health & Safety, Environmental Standards and Operational requirements as required
to continuously learn about organisational product and service offerings, keeping up to date with any changes
validation engineer
Working hours
part-time
Responsibility
life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients
we are PCI
our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI
to ensure the qualified state of all cGMP facilities, utilities, manufacturing, packaging and analytical equipment at PCI Tredegar is maintained in accordance with the required risk based, lifecycle approach
to take part in Risk Assessments to determine the validation approach for Facilities, Utilities and Equipment, ensuring those which have a GxP impact are appropriately qualified
to ensure the documentation utilised for Facilities, Utilities and Equipment Qualification has been generated in compliance with Statutory, Regulatory, Client and Company expectations
to work closely with Project Management Teams in Pharmaceutical Development, Technical Affairs, Operations , Supply Chain and Clients to ensure projects are progressed in a timely manner
to ensure the Site Validation Master Plan is adhered to and maintained in accordance with a risk based, lifecycle approach
project engineer
Working hours
full-time
Responsibility
life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients
we are PCI
we have exciting permanent opportunity available for an Project Engineer to join our Engineering Department, based at Hay on Wye
specification, development, purchase and introduction of site facility, production equipment tooling and processes in line with the companies and customers’ needs
liaise with other departments and suppliers during the specification of new equipment to ensure fit for purpose is achieved
identification of future Capital investment projects to improve the business offerings and competitive edge
our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI
raising of site capital application requests
audit senior
Working hours
full-time
Responsibility
life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients
we are PCI
co-ordinate and manage the Bridgend client and regulatory audit schedule
manage the supplier, audit, and risk module within Master Control for the ongoing audit system at Bridgend
supporting Bridgend regulatory site licences
support continuous improvement projects and opportunities
our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI
support with any quality related questionnaires for customer vendor approval of Bridgend
Requirements
experience in a Quality role within a regulated industry
experience in performing audits, internally and externally
experience generating reports or technical documentation within a regulated industry
strong communication skills
HNC, HND or degree in a life sciences subject or suitable experience in a Quality Assurance or technical role within the pharmaceutical industry
the ability to introduce, co-ordinate, complete and close audit reports
experience in a Quality Assurance role within an industry with transferable skills
A high level of self-motivation is required
senior finance manager
Working hours
full-time
Responsibility
life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients
we are PCI
lead process, system, and data continuous improvement projects targeting the Quote to Cash process
prioritize opportunities, build business cases and project manage projects
implement best practices, process improvements, and standardize across business
support/Lead Master Data projects
our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI
create, publish, and monitor key performance metrics in the Quote to Cash process to monitor process health
Requirements
bachelor's Degree in a related field and/or 7-10 years related experience and/or training
be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables
lean Six Sigma / Process improvement experience
experience supporting Quote to Cash process
experience in Business Partnering in a large company environment
experience implementing process improvements
intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs
full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs
business development manager
Working hours
full-time
Responsibility
life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients
we are PCI
primary business contact for the territory for PCI International services providing weekly team updates and sales reports
regular travel for face-to-face meetings with potential and existing clients within the Territory
our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI
clearly follow company KPI’s and identify the decision structure and process for outsourcing of both existing and prospective clients
drive new business and revenue growth to meet sales targets for the assigned territory and named accounts within Europe for PCI International
identifying and presenting the company’s value proposition to the territory, including opportunities for strategic bundling of the company’s services
Requirements
educated to degree level
join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
A proven track record in sales, within the pharmaceutical industry within the dedicated region
experience and knowledge with the pharmaceutical drug development, manufacturing, and packaging process
highly developed board level negotiation skills
team leadership skills
excellent customer facing skills
A proven ability in reporting progress and tracking leads
finance manager
Working hours
full-time
Language
english
Responsibility
life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients
we are PCI
our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI
perform any other reasonable tasks associated with the activities of the Finance Department or the Company as a whole, as requested
support with financial reporting
manage accounts payable and receivable functions
Requirements
essential
relevant experience in a Finance Manager role
understanding of credit control
knowledge of the structure of data tables together with the importance of data format
excellent numeracy and literacy skills
ability to use Microsoft Office packages to record, analyse and communicate information
excellent verbal and written communication skills
team player and good interpersonal skills
quality assurance manager
Working hours
full-time
Responsibility
life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients
we are PCI
we are looking for Quality Assurance Manager to join our office in Bridgend, Wales
generate and report on QMS KPls to monitor compliance and effectiveness of the QMS
promote a culture of zero overdues and proactively follow up with staff to ensure completion of actions within timelines
write quality related standard operating procedures
our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI
provide quality assistance in investigation and resolution of internal and external quality issues applying risk management principles
senior engineer
Working hours
full-time
Language
english
Responsibility
ensure that maintenance areas and equipment are kept in a clean, tidy and secure state
adherence and recording of defined routine maintenance schedules; covering all equipment and plant
monitor and analyse production performance and targets in line with engineering KPI’s and assessing for continuous improvement
highlight potential areas for improvement within Production area regarding equipment or procedural changes
strip down, cleaning and reassembling of production equipment as per routine maintenance schedules
perform machine set ups and changeovers to target times as required in line with production requirements
to actively assist in looking at ways to improve changeover times by procedure and method
ensure all planned preventive maintenance is carried out when required and documented accordingly
Requirements
proven relevant experience in an industrial maintenance environment
mechanically experienced with an industry standard qualification
possess a broad knowledge of; Electrical systems, Pneumatic systems, Mechanical systems and Hydraulic systems
knowledge of good engineering practice
conversant in the use of hand tools and operating workshop equipment
ability to communicate effectively in written and spoken English and capable of adapting language to the situation or audience