Senior Technical Writer
Senior Technical Writer
Posted on :
04-10-2024
Employer Active
1 Vacancy
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Job Description
About PSC Biotech
Who we are
PSC Biotech is a leading Biotech Consultancy firm founded in 1996 headquartered in Pomona California USA with Global operations in Ireland India Singapore Australia and the US serving 350 clients in more than 23 countries worldwide. We provide cloudbased software solutions for Quality Management and Regulatory Inspections pharmaceuticals contract manufacturing professionals and metrology services to our clients.
PSC Biotech is a leading Biotech Consultancy firm founded in 1996 headquartered in Pomona California USA with Global operations in Ireland India Singapore Australia and the US serving 350 clients in more than 23 countries worldwide. We provide cloudbased software solutions for Quality Management and Regulatory Inspections pharmaceuticals contract manufacturing professionals and metrology services to our clients.
Take your Career to a new Level
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of likeminded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diversecultural work setting.
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of likeminded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diversecultural work setting.
Employee Value Proposition
Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client s expectations with regards to quality of all scalable and business unit deliverables staying under budget and ensuring timelines for our deliverables are being met.
Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client s expectations with regards to quality of all scalable and business unit deliverables staying under budget and ensuring timelines for our deliverables are being met.
Job Summary:
- An exciting opportunity has opened in the *** Manufacturing Support team for a Technical Writer.
- In this role you will be responsible for owning and managing change controls critical to site development and managing the operational doentation updates as required by each project.
- This role is primarily based onsite.
Primary Responsibilities:
- Develop/ Update and maintain Operations procedures in accordance with site and corporate requirements.
- Serve as a doent owner.
- ist in generation of training materials and may ist in providing training on scientific or technical aspects of the process.
- Liaise with Manufacturing/Inspection/Engineering regarding doentation changes in an effective and timely manner.
- Develop protocols for in Manufacturing & Inspection in support of change controls nonconformances & troubleing investigations with support from relevant SMEs.
- Involvement in projects as part of continuous process improvement and / or troubleing.
- Ownership and management of change controls as required.
- Issuance and updates of paper batch records in line with production schedule.
- Liaise with Quality urance to ensure that GMP standards are maintained in line with current OS.
- Partner with Operations lead/appropriate SME to ensure updates are correct and aligned with project deliverables/ timelines.
- Perform doent trending upon project completion to identify keys issues/mistakes in doent processing.
- Support data verification of Operations owned protocols reports and risk essments.
- Support the production support team in reducing doent turnaround times.
- Use specified software packages and standard procedures responsible for compiling and maintaining all relevant doentation including SOPs.
- Provide technical and clerical support to the manufacturing inspection & engineering teams in the preparation of doentation collation of data and tracking of SOPs.
- Ensure Nonconformance are triage within the elished goal and serve as a deviation owner for minor deviations.
- Own corrective /preventative actions and effectiveness verification.
- Support of C&Q characterisation functional testing protocols as required by project. NOTE: This may require flexible working hours.
Requirements
Knowledge/Ss:
- Strong Project Management and organizational ss including ability to follow ignments through to completion.
- Excellent verbal and written communication ss: Strong Technical writing ss for GMP doentation (e.g. investigations procedures change controls) and good Presentation ss.
- Escalate issues professionally and in a timely manner.
- Ensures compliance within regulatory environment.
- Demonstrated ability to work independently and deliver right firsttime results under minimal direction.
- Experience participating in and leading crossfunctional teams.
- Experience in managing multiple competing priorities in a fastpaced environment.
Relevant Experience:
- Bachelor s degree in a Science or Engineering discipline.
- 3 years of experience in Chemistry/Microbiology/Engineering/Validation gained within a biotech pharma or health care organization.
- Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products an advantage.
#LIXA1
Knowledge/Ss: Strong Project Management and organizational ss, including ability to follow ignments through to completion. Excellent verbal and written communication ss: Strong Technical writing ss for GMP doentation (e.g., investigations, procedures, change controls) and good Presentation ss. Escalate issues professionally and in a timely manner. Ensures compliance within regulatory environment. Demonstrated ability to work independently and deliver right first-time results under minimal direction. Experience participating in and leading cross-functional teams. Experience in managing multiple, competing priorities in a fast-paced environment. Relevant Experience: Bachelor s degree in a Science or Engineering discipline. 3+ years of experience in Chemistry/Microbiology/Engineering/Validation gained within a biotech, pharma or health care organization. Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products an advantage. #LI-XA1
Employment Type
Full Time
Key Skills
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