Documentation Specialist Vaccines IPT

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.

An amazing opportunity has arisen for a Documentation Specialist Vaccines IPT. 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.

What you will do:

Bring energy, knowledge, innovation, and leadership to carry out the following:

Creating, editing, and formatting of SOPs, Work Instructions, and other documents on the EDMS 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.

Part-take in cross-functional problem-solving 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.

Requirements

What skills you will need:

In order to excel in this role, you will need to have:

3-5 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.