Senior Technical Writer
- East
- Contract
- Life Sciences
This vacancy has now expired
Ireland is a hive of activity for the Life Sciences Sector at present with global players setting up new and expanding existing manufacturing facilities all over the Country. An exciting opportunity has arisen to work via Quanta on the client’s side for a global Pharmaceutical organisation on a major expansion project based in the picturesque Munster region of Ireland.
Located just 20 minutes from the nearest international airport, the manufacturing site is workable for those wishing to commute to/from Ireland for a contract position. You will be required on site for 5 days per week Monday – Friday working 45 hours.
Role Summary:
- Collaborate with subject matter experts and key functional department personnel to ensure timely development and accurate content of GMP documents (e.g. standard operating procedures, system design documents, and work instructions)
- Perform retrospective assessment of computerised system administration activities and author the resulting reports.
- Maintain an awareness and understanding of current site document requirement, document control procedures, and good documentation best practices. Review internal GMP documents to ensure they are compliant with these expectations and suggest improvements.
- Manage and coordinate activities related to document creation using the Electronic Document Management System, including document initiation, workflow support, revision, and retirement.
- Conduct compliance review of electronic work tickets for adherence to Good Documentation Practices/Requirements
- Facilitate cross-functional collaboration of cGMP documentation with technical experts and stakeholders to reach consensus and ensure document approval timelines meet business needs.
- Own and/or support GMP document-related Change Controls/CAPAs.
Education and Experience
- Associate Technical Writer Requires BS/BA in Life Sciences, Engineering, English or
- related field or equivalent combination of education and experience.
- Technical Writer: Requires BS/BA in Life Sciences, Engineering, English or related field and 2 years of relevant experience or equivalent combination of education and experience.
- Senior Technical Writer: Requires BS/BA in Life Sciences, Engineering, English or related field and 5 years of relevant experience or equivalent combination of education and experience.
- Strong knowledge of Good Documentation Practices (ALCOA), ISPE Standards, GAMP5, and Documentation Management/Life Cycle guidance
- Applies excellent collaboration skills, via multiple communication types, in a steady paced environment.
- Strong writing and proofreading skills in a technical and scientific capacity.
- Ability to organise and author technically complex information into laymen suitable documentation.
- Ability to maintain keen attention to detail with a high regard for quality, efficiency, and processes.
If this role is of interest to you, please apply now!
#LI-CH3
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
Save as job alert
Similar Jobs
Salary
Competitive
Location
Cork
Salary
Competitive
Sector
Compliance / Quality Assurance
Job type
Contract
Location
Ireland
Cork
Description
EHS Specialist - Ireland, Cork - 12 Months Contract Would you like the opportunity to work alongside a global health care product manufacturer who are the leaders in the production of
Reference
37109
Expiry Date
01/01/0001
Author
Farhan YounasAuthor
Farhan YounasSalary
Competitive
Location
Cork
Salary
Competitive
Sector
Compliance / Quality Assurance
Job type
Contract
Location
Ireland
Cork
Description
Utility Project Engineer - Ireland, Cork - 12 Month Contract Would you like the opportunity to work alongside a global healthcare product manufacturer who are the leaders in the production of
Reference
37111
Expiry Date
01/01/0001
Author
Farhan YounasAuthor
Farhan YounasSalary
Competitive
Location
Dublin
Salary
Competitive
Sector
Compliance / Quality Assurance
Job type
Contract
Location
Ireland
Dublin
Description
Qualified Person - Ireland, Dublin - 12 Month Contract One of the top 10 best companies to work in Ireland is looking for Qualified Person for their large-scale new facility in Dublin. Is this
Reference
37115
Expiry Date
01/01/0001
Author
Tara BeresfordAuthor
Tara BeresfordInsights
Send us your CV
Our candidates are the cornerstone of our organisation and we are always looking to connect with new professionals who are seeking their next contract assignment or career opportunity.
Christopher
I manage this role.