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Description
auto req 11780br
job posting title production technical writer
career category manufacturing
employee subgroup salaried ft
country (state/region) ireland
location (city) dun laoghaire
amgen job description the activities performed in the role of production technical writer include:experience in aseptic manufacturing operations would be an advantage.
. attend appropriate training sessions and meetings when requested.review and update prodcution standard operating procedures, develop.fda,
. contribute and assists with corporate, imb auditors and other regulatory bodies during company audits.
he/she will be part of a learning and development programme which will include goal setting, annual performance reviews and individual development plans.
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.be educated to degree level or equivalent.
the job holder will be a champion for safe working practices and safety initiatives within their functional area.
. provide technical and clerical supoprt to the prodcution team in the prepaartion of documetnation, colltaion of data and trakcing of investgiations
.
preefrred qualifciations .
. comlpete production corrcetive aciton tracking commitments.
basic qualifications applicants should:
. prepare and track production change notification requests
.
. have with 3-5 years experience in the chemistry/microbiology/validation function of a pharmaceutical/healthcare industry.review and update master/generic batch records,
. develop, bills of materials etc.
. liase with quality assurance to ensure that gmp standards are maintained in line with current sop\'s, batch documentation and licences.
. liase with technical services regarding documentation changes in an effective and timely manner.
. use specified software packages and standard procedures, responsible for compiling and maintaining all relevant documentation including batch documentation, bills of materials and sop\'s for submission to the production team leader.
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