Documentation Specialist

Found in: Talent IE C2 - 3 weeks ago

Cork, Ireland PSC Biotech Ltd Full time
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 Documentation Specialist. He/She will provide documentation (creating, formatting, tracking of SOPs, Work Instructions etc in the client Electronic Document Management Systems) support to the Vaccines IPT team and the role will be reporting to the Vaccines IPT Associate Director.



Requirements

What you will do:

·        Creating, editing, and formatting of SOPs, Work Instructions, and other documents on the client 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 at client 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.

 

What skills you will need:

·        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.



#LI-KV1

Requirements
What you will do: · Creating, editing, and formatting of SOPs, Work Instructions, and other documents on the client 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 at client 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. What skills you will need: · 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. #LI-KV1

  • Documentation Specialist

    Found in: Talent IE C2 - 3 weeks ago

    Cork, Ireland PSC Biotech Ltd Full time

    About PSC BiotechWho 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...

  • QA Documentation Specialist

    3 weeks ago

    Cork, Ireland Westbourne IT Global Services Full time

    An exciting opportunity has arisen for a QA Documentation Specialist and system specialist, who will support all administrative tasks in relation the training Dept, to GxPLearn system and to GVault system across the site Main Duties & Responsibilities ·Provides clerical and administrative support related to GxPlearn and GVault. ·Responsible for...

  • Documentation Specialist

    3 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,...

  • Associate Specialist

    Found in: Talent IE C2 - 2 weeks ago

    Cork, Ireland PSC Biotech Ltd Full time

    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...

  • MSAT Specialist- Thermal

    Found in: beBee jobs IE - 6 days ago

    Cork, Cork, Ireland Cpl Full time

    Kenny-Whelan (a specialist division of the CPL group) are hiring a MSAT specialist -Thermal Validation to work on contract at Janssen Sciences in Ringaskiddy CorkMSAT Specialist – Thermal (12 months) Location: Ringaskiddy, Cork, Ireland Reports to: Manager, Manufacturing Science & Technology Position Summary: We have an exciting opportunity for a MSAT...

  • IT/OT Specialist

    5 days ago

    Cork, Ireland Uniting Holding Full time

    OT/IT Specialist As an OT/IT Specialist at DataLogiX, you will be responsible for collaborating with our clients to understand their IT requirements in manufacturing networks. You will help design and implement IT systems and solutions to meet their requirements. In this role, you will work closely with cross-functional teams, including IT, engineering,...

  • MSAT Specialist- Commercial Products

    Found in: beBee jobs IE - 6 days ago

    Cork, Cork, Ireland Cpl Full time

    Kenny-Whelan (a specialist division of the CPL group) are hiring a MSAT specialist -Commercial Products to work on contract at Janssen Sciences in Ringaskiddy CorkWe have a great opportunity for a MSAT Specialist to join our MSAT team at the Ringaskiddy site. This would be approximately a 12-month contract position. The MSAT Specialist is an integral...

  • Validation Specialist

    Found in: beBee jobs IE - 2 weeks ago

    Cork, Cork, Ireland Orion Group Full time

    Orion Group Life Sciences are currently recruiting a Validation Specialist on behalf of our Multinational Biopharmaceutical Client based in Cork on an initial 11-Month contract with potential to extend. Job DescriptionAn amazing opportunity has arisen for a Contractor - Vaccines IPT. The Contractor will provide validation (primarily cleaning cycle...

  • Validation Specialist

    Found in: beBee S IE - 4 weeks ago

    Cork, Ireland Orion Group Full time

    Orion Group Life Sciences are currently recruiting a Validation Specialist on behalf of our Multinational Biopharmaceutical Client based in Cork on an initial 11-Month contract with potential to extend. Job DescriptionAn amazing opportunity has arisen for a Contractor - Vaccines IPT. The Contractor will provide validation (primarily cleaning cycle...

  • MSAT Specialist- Junior technical Operations

    Found in: beBee jobs IE - 3 days ago

    Cork, Cork, Ireland Cpl Full time

    Kenny-Whelan (a specialist division of the CPL group) are hiring a MSAT specialist -Junior tech Operations to work on contract at Janssen Sciences in Ringaskiddy CorkWe have a great opportunity for a MSAT Specialist to join our MSAT team at the Ringaskiddy site. This would be approximately a 12-month contract position. The MSAT Specialist is an integral...

  • QA Specialist I

    Found in: beBee S IE - 3 weeks ago

    Cork, Ireland Orion Group Full time

    Orion Group are sourcing a QA Specialist on behalf of our Multinational Biopharmaceutical Client on an initial 12-month contract located in Cork. This is a contract role for a QA Specialist, within the GSIUC QA Department under the QA packaging and labelling support team. The successful candidate will be required to perform QA approval and release of...

  • Global Shares

    3 weeks ago

    Cork, Ireland JPMorgan Chase & Co. Full time

    The Global Shares Transaction was announced on March 15, 2022. Founded in 2005, Global Shares is a leading cloud-based provider of share plan management software. Global Shares’ employee ownership solutions cover the entire company lifecycle, and caters to corporates worldwide. As a Global Shares - Contract Specialist in our Legal department, you will...

  • Global Shares

    Found in: Talent IE C2 - 3 weeks ago

    Cork, Ireland JPMorgan Chase & Co. Full time

    The Global Shares Transaction was announced on March 15, 2022. Founded in 2005, Global Shares is a leading cloud-based provider of share plan management software. Global Shares’ employee ownership solutions cover the entire company lifecycle, and caters to corporates worldwide. As a Global Shares - Contract Specialist in our Legal department, you will...

  • IT Governance Specialist

    7 days ago

    Cork, Ireland Deutsche Börse AG Full time

    Your career at Deutsche Börse Group IT Governance Specialist –Corporate IT – Risk Management, Controls & Governance (f/m/d) Duration: Permanent Contract: Permanent DBAG, CIO / COO, Corporate IT, Risk Management, Controls & Governanc e Field of activity Corporate IT is on a journey of cultural transformation: we are facing the challenges of the...

  • QA Specialist II

    Found in: Talent IE C2 - 4 days ago

    Cork, Ireland Gilead Sciences Ireland UC Full time

    Description QA Specialist II position in QA General Operations, Gilead Sciences Ireland UC Cork Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care...

  • AML QA Specialist

    Found in: Talent IE C2 - 3 weeks ago

    Cork, Ireland Amazon Ireland Support Services Limited - A94 Full time

    The AML Programme team in Registration and Compliance (R&C, part of Selling Partner Risk) is looking for a Dutch-speaking quality control specialist to join a team of quality specialists covering the Know Your Customers programme. The role is critical to ensure that Amazon’s payments businesses expand with appropriate controls and quality processes in...

  • AML QA Specialist

    Found in: Talent IE C2 - 3 weeks ago

    Cork, Ireland Amazon Ireland Support Services Limited - A94 Full time

    The AML Programme team in Registration and Compliance (R&C, part of Selling Partner Risk) is looking for a Chinese-speaking quality control specialist to join a team of quality specialists covering the Know Your Customers programme. The role is critical to ensure that Amazon’s payments businesses expand with appropriate controls and quality processes in...

  • AML QA Specialist

    Found in: Talent IE C2 - 3 weeks ago

    Cork, Ireland Amazon Ireland Support Services Limited - A94 Full time

    The AML Programme team in Registration and Compliance (R&C, part of Selling Partner Risk) is looking for a Portuguese-speaking quality control specialist to join a team of quality specialists covering the Know Your Customers programme. The role is critical to ensure that Amazon’s payments businesses expand with appropriate controls and quality processes in...

  • QA Specialist II

    Found in: Talent IE C2 - 4 days ago

    Cork, Ireland Gilead Sciences Full time

    Job Description For Current Gilead Employees and Contractors: Please log onto your to apply for this job. At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to...

  • Partner Programs Specialist

    Found in: Talent IE C2 - 2 days ago

    Cork, Ireland Cloudera Full time

    Job Description :  At Cloudera, we empower people to transform complex data into clear and actionable insights. With as much data under management as the hyperscalers, we're the preferred data partner for the top companies in almost every industry. Powered by the relentless innovation of the open source community, Cloudera advances digital transformation...