Documentation Specialist

About PSC Biotech

Who are we

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.

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.

Overview:

The candidate will provide documentation (creating formatting tracking of SOPs Work Instructions etc in the Electronic Document Management Systems) support to the Vaccines IPT team and the role will be reporting to the Vaccines IPT Associate Director.

Requirements

Responsibilities:

• Creating editing and formatting of SOPs Work Instructions and other documents on the EDMS (Veeva Vault) from material supplied by the Vaccine IPT SMEs.
  
• Liaison with key stakeholders e.g. Quality Change Control SMEs etc. to ensure compliance correctness content and delivery.
  
• Lead the tracking and maintaining of the project document delivery schedules for the team (using Excel).
  
• Engage with Change Control and the wider project team to ensure documents are prepared and updated in time for different stages of C&Q execution and production.
  
• Provides to the site knowledge and experience in Quality Documentation Systems.
  
• Responsible for use of the Site Documentation System including Issuance reconciliation storage archiving and retrieval of cGMP documentation to support the manufacture & testing of our products.
  
• Responsible for maintaining the Site Master file for current effective cGMP documents on site
  
• Uses knowledge to improve Quality Documentation Systems solve problems provide continuous improvement and execute tasks.
  
• Provides compliance contribution to project teams and leads small projects.
  
• Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
  
• Parttake in crossfunctional problemsolving teams for troubleshooting and investigations within Vaccines IPT
  
• Ensure compliance with site EHS policy cGMP and other business regulations and support Technical IPT input to risk assessments audits regulatory inspections and incident investigations.
  
• Ensure the highest Quality Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements including ownership as relevant.
  

Skills Required:

• In order to excel in this role you will need to have:
  
• 15 years experience as a documentation specialist or equivalent in a pharmaceutical or a highly regulated environment.
  
• Experience in maintaining and updating excel schedules 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 a pharmaceutical environment.
  
• Desirable: Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. Manufacturing Quality Engineering Tech Services etc).
  
• Desirable: Qualification in a biological science subject.
  
• Desirable: Evidence of Continuous Personal Development.
  

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