QA VALIDATION ENGINEER
TARGET START DATE: June 2018
LENGTH OF ASSIGNMENT: 12 months +
LOCATION: Grand Bahama.
As a member of the Quality organisation, the QA Validation Engineer is responsible for ensuring that all qualification and validation activities conducted by the client or approved third parties, comply with Company, Quality and regulatory requirements and expectations. This is a wonderful opportunity to be part of a start up facility project.
The QA Validation Engineer is responsible for:
- Providing hands on support, guidance and direction to all areas of the organisation including its third-party contractors.
- Support all Plant activities, scheduling and any other department or function within the organisation that requires support related to Qualification and validation.
- Scheduled qualification and validation activities as part of process / facility changes / improvements, deviations, customer and regulatory inspections etc.
- Assisting with the development of validation documentation (plans, protocols, reports etc.)
- Facilitating and performing supporting activities as required:
- Generation and review/approval of deviations.
- CAPAs, change requests & SOP/Work instructions.
- Risk Assessments & System Impact Assessments.
- Periodic key performance indicator reporting
- Supporting documentation necessary to perform the necessary qualification or validation activities.
- Supervisory experience for new Plant and management of third party providers
- Plan, execute or coordinate the qualification and validation activities as required
- Cleaning Validation and Process Performance Qualification (PPQ)/Process Validation (PV) in Plant 3, system walk-downs, environmental monitoring program etc.
- 7- 10 years of hands on experience in Equipment Qualification & Process Validations
- Pharmaceutical/ Biopharmaceutical experience under cGMP regulations
- API experience is highly desirable
- S. , M.S. or MBA in Science, Biology, Chemistry, or Engineering.
To find out more about this new opportunity please send your CV to firstname.lastname@example.org or for a confidential conversation call Barry Jones on +353 21-2363154
TARGET START DATE: June 2018
LENGTH OF ASSIGNMENT: Permenant
The primary function of the role is to support the senior management in all aspects of the company’s business from supporting the operational day to day activities to project execution. As the company continues to grow and expand, comes the opportunity for personal development and progression into either a more senior admin role or into a more specialized functional role.
- Supporting Senior Managers and functions as required (CEO, COO, HR, Finance, Quality, etc.)
- Booking Flights, hotels and other travel, controlling expenses, booking meeting rooms, coordinating client visit schedules, arranging visas
- Diary management and administration support for the CEO
- Filing / handling inbound and outbound mail / general office management / ordering stationery etc
- Reception duties
- Assisting in the compilation and editing of documents
- Assisting with project work as required
- Assisting in the implementation and continuous improvement of the KPC Quality Management System
- Assisting in HR administration, supporting the recruitment process and the maintenance of training files
- Supporting on IT requirements; liaising with IT suppliers, hardware/software/website updates
- Self-motivated, proactive and well organized
- Strong attention to detail
- Excellent verbal and written communication skills.
- Third level diploma / degree in Business Studies or other relevant qualification
- Minimum 2 – 5 years’ experience in a busy office
- Exposure in working in a start-up environment would be highly desired
- PA experience is essential
- Exposure to documentation control will be preferred
- A high level of capability in MS Office (Word, Excel, Powerpoint) is essential.
TECHNICAL OPERATIONS SPECIALIST
TARGET START DATE: End of July
LENGTH OF ASSIGNMENT: Permanent Position
LOCATION: Cork, Ireland
The Technical Operations Specialist will become a member of the Team on site at KPC Cork. This is a new role for a highly motivated individual to learn Bio Pharmaceutical/ Pharmaceutical Project Management/Consultancy on both an Irish and International stage.
The successful candidate will report to our Senior Technical Transfer & Operational Readiness consultant and deliver on a broad range of high level project management and technical services for our Clients.
- Support the Senior Technical Transfer/ Project Managers for customer service & project activities
- Support on activities such as tech transfer, validation and operational readiness lifecycle – e.g. Planning, development of documentation (protocols, assessments, reports) in support of Tech Transfer, project management and Operational Readiness activities, running meetings etc.
- Travelling to Customer sites – Providing on-site / off-site support as required
- Liaise with on-site KPC and Client Engineers/Scientists to support projects deliverables
- Participate in Business Development and Marketing Projects
- Assist and participate in KPC workshops, forums and meetings for Irish and International customers
- Bachelor of Science or related degree in Life Sciences, Pharmaceutical Sciences or Chemical/Biochemical Engineering
- Minimum 1 to 3 years’ experience
- Strong technical communication and writing skills
- Strong working knowledge of Word, Excel, Powerpoint etc.
- Experience or knowledge of equipment validation in the pharmaceutical industry is desirable
- Ability to work cross functionally and meet tight deadlines
- An excellent communicator, ability to develop and maintain relationships
- Working knowledge of NPI/Tech Transfer/ Project Management/ Risk Assessment/ Quality & Validation processes (Process, Equipment, Cleaning) are desirable.
To find out more about this new opportunity please send your CV to email@example.com or for a confidential conversation call Barry Jones on 021-2363154