Technical Writer
- North America, United States
- Contract
- CAPEX Projects
This vacancy has now expired
Our client, a global pharmaceutical manufacturing organization are looking for a talented Technical Writer to join their expanding team. They are making an investment of more than $2 Billion USD to establish a new large-scale cell culture production site in the United States to accelerate the growth of its biopharmaceutical contract development and manufacturing business. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States.
Main Responsibilities;
- Support CQV through all phases of the Project for cGMP Documentation generation and execution. This includes but not limited to: CQV Validation Master Plan, Validation Project Plans, System Impact Assessment Report, URS’s, DQ’s, RTM’s, QRA’s, PPPS’s, FAT protocols, IV protocols, OV protocols and all Final and Summary Reports.
- Act as CQV SME on all queries relating to all CQV cGMP Documentation both generated documents and executed documents.
- Ensure all cGMP documentation deliverables are met.
- Arrange and coordinate all facilitated reviews relating to all cGMP documents.
- Where required, coordinate and support system to ensure full approvals for CQV pre-req documents.
- Coordinate daily deliverables for cGMP documentation generation team
- Collaborate with cross-functional teams to develop and/or edit CQV validation documentation including, but not limited to URS’s, DQ’s, RTM’s, VMP’s, VPP’s that define system and equipment requirements.
- Review and approve CQV validation documents to ensure they are clear, concise, and meet regulatory standards.
Requirements;
- 5-10 years in a similar technical writing role for cGMP Documentation.
- Minimum 5 years documentation management experience on Large Scale Projects.
- Experience with liaising with other departments and engineers/QA, ensuring streamlined processing of project documentation or similar type documentation process.
- Willingness to take action in a proactive manner for driving progress.
- Strong communication skills.
- BA/BS in a related field and 5+ years experience successfully executing complex projects in a Pharma/cGMP environment.
If this role is of interest to you, please apply now!
#LI-MC1
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
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
Save as job alert
Similar Jobs
Salary
Competitive
Location
Barceloneta
Salary
Competitive
Sector
CAPEX Projects
Job type
Contract
Location
North America
United States
Description
CapEx Project Manager - Puerto Rico - 12-month contract We are recruiting on behalf of a leading global pharmaceutical client based in the surroundings of Barceloneta. Due to a large capital
Reference
38081
Expiry Date
01/01/0001
Author
Kristen ScottAuthor
Kristen ScottSalary
Competitive
Location
Barceloneta
Salary
Competitive
Sector
Life Sciences
CAPEX Projects
Job type
Contract
Location
North America
United States
Description
Project Engineer - Puerto Rico - 12-month contract We are recruiting on behalf of a leading global pharmaceutical client based in the surroundings of Barceloneta. Due to a large capital investment
Reference
38028
Expiry Date
01/01/0001
Author
Kristen ScottAuthor
Kristen ScottSalary
Competitive
Location
Ohio
Salary
Competitive
Sector
CAPEX Projects
Job type
Contract
Location
North America
Central
Description
CAPEX Project Manager – Ohio – Pharmaceuticals – Contract This is a fantastic opportunity for a CAPEX Project Manager to join our major, global pharmaceutical client on their latest
Reference
38110
Expiry Date
01/01/0001
Author
Annabel NangleAuthor
Annabel NangleInsights
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.
Mark
I manage this role.