Ad Details
Location:
Description
auto req 11789br
job posting title process validation specialist
career category manufacturing
employee subgroup salaried ft
country (state/region) ireland
location (city) dun laoghaire
amgen job description the activities of the process validation specialist are to:
he/she will be part of a learning and development programme which will include goal setting, annual performance reviews and indiivdual development plans.oq, equimpent and systems in conjunction with suppliers as appropriate,
. perform iq, pq valiadtion on procseses.
. attend and contribute to staff meetings and attend appropriate training sessions, as reqiured.the successful candidate should also demonstrate drive for results, creative and analytical thinking, and a focus on quality.
. assure that all validation test procedures are in line with current technology, corporate and governmental regulations.
. problem solving ability and excellent oral and written communications skills
.
basic qualifications .
. provide expert technical support in validation to meet objectives of quality, trouble shooting, standardising and improving new and existing equipment, output and cost in developing.engineering and validation batches to ensure appropriate conditions are met and required samples are taken,
. monitor trial.
. ideally 2-5 years previous validation experience in an fda regulated manufacturing envirnoment.co-ordniate the individual takss required to valdiate processes, equipment etc.docmuent and reoprt validation protcools in line with gmp\'s and otehr regualtory requierments and stanadrds, exeucte,
. preapre. review and update standard operating procedures (sop\'s) in accordance with site and corporate requirements,
. write.kaye etc, datatrace, g. word, dms, excel.).
. compile and maintain all relevant documentation for submission to management (protocols and reports).
key competencies we are looking for are: customer service, and planning and prioritisation, honesty and consistency.as a member of multidisciplinary site teams, e, when required,
. participate.minimum batchelor of science/engineering degree or equivalent.
. use specified software packages (e.
. comply with the responsibilities as outlined in the site safety statement
the successful candidate will perform all tasks with due care and attention and in accordance with good manufacturing practices and amgen\'s requirements, policies and procedures.
. knowledge of cgmp\'s and other world wide regulatory requirements.if required
, co-ordinate shipment of samples.g. cross functional investigation team.
. co-ordinate delivery of samples to the laboratories and co-ordinate testing of same
.
the job holder will be a champion for safe working practices and safety initiatives within their functional area.computer knowledge / word processing skills.
Contact Now