Documentation Specialist

4 weeks ago

Cork, Ireland PSC Biotech Full time
  • Industry Pharma/Biotech/Clinical Research
  • Work Experience 4-5 years
  • City Cork
  • State/Province Cork
  • Country Ireland
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 cloud-based 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 like-minded 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 diverse-cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house 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 Title: Documentation Specialist

Job Description:

An amazing opportunity has arisen for a DocumentationSpecialist. He/She will provide documentation (creating, formatting, trackingof SOPs, Work Instructions etc in the client Electronic Document ManagementSystems) support to the Vaccines IPT team and the role will be reporting to theVaccines IPT Associate Director.

Requirements

What you will do:

· Creating, editing, and formatting of SOPs, WorkInstructions, and other documents on the client EDMS from material supplied bythe Vaccine IPT SMEs.

· Liaison with key stakeholders e.g., Quality,Change Control, SMEs etc. to ensure compliance, correctness, content, anddelivery.

· Lead the tracking and maintaining of the projectdocument delivery schedules for the team (using Excel).

· Engage with Change Control and the wider projectteam to ensure documents are prepared and updated in time for different stagesof C&Q execution and production.

· Provides to the site knowledge and experience inQuality Documentation Systems.

· Responsible for use of the Site DocumentationSystem including Issuance, reconciliation, storage, archiving and retrieval ofcGMP documentation to support the manufacture & testing of our products.

· Responsible for maintaining the Site Master filefor current effective cGMP documents at client site.

· Uses knowledge to improve Quality DocumentationSystems, solve problems, provide continuous improvement, and execute tasks.

· Provides compliance contribution to projectteams and leads small projects.

· Makes decisions within guidelines and policieswhich impact own priorities and allocation of time to meet deadlines.

· Part-take in cross-functional problem-solvingteams for troubleshooting and investigations within Vaccines IPT

· Ensure compliance with site EHS policy, cGMP andother business regulations and support Technical IPT input to risk assessments,audits, regulatory inspections, and incident investigations.

· Ensure the highest Quality, Compliance andSafety standards by participating and complying with our Manufacturing DivisionQuality Management System (QMS) requirements, including ownership, as relevant.

What skills you will need:

· 3-5 years’ experience as a documentationspecialist or equivalent in a pharmaceutical or a highly regulated environment.

· Experience in maintaining and updating excelschedules and trackers for small projects.

· Advanced PC skills such as Excel, Word,PowerPoint.

· Stakeholder management of multi decision makers,colleagues, peers, and cross functional teams.

· Knowledge and experience of GMP and GDP in apharmaceutical environment.

· Desirable: Demonstrated knowledge in more thanone pharmaceutical and/or chemical manufacturing operation (e.g.,Manufacturing, Quality, Engineering, Tech Services etc).

· Desirable: Qualification in a biological sciencesubject.

· Desirable: Evidence of Continuous PersonalDevelopment.

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