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Operations Documentation Specialist

Employer
i-Pharm Consulting
Location
Republic of Ireland, Dublin, Dublin North
Salary
EUR50000 - EUR55000 per annum
Start date
18 May 2023
Closing date
15 Jun 2023

View more

Discipline
Quality
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Job Details

Role Functions

(Functions include, but are not limited to, the following)

· Responsibility for the timely, accurate and efficient management of documents including access and revision control.

· Manage and implement on the floor documentation control system.

· Creation and revision of Standard Operation Procedures (SOP's), Work Instructions (WI's) are required.

· Drive the Documentation life cycle system to ensure documents are approved in timely manner as per scheduling requirements.

· Work with SME's and various internal and external stakeholders to ensure technical documentation updates are created and approved.

· Collaborate with QA, Supply chain and Operations core functions.

· Ensure Compliance with all regulatory GMP, Safety and Environmental Requirements.

· Report status of documents, identify areas of opportunities and action plans required.

· Coordination of Quality Notifications, CAPA's and overall Deviation management.

· Manage ''Live'' Documentation updates and report progress on documents

· Ensure effective planning, common understanding and targets for specific documentation

· Maintains a thorough knowledge of documentation needs.

· Provide updates on a regular basis to functional directors, associate directors managers on deviation, documentation and CAPA's.

· Identify Risks, Gaps and Opportunities related to documentation - work with Area Owners and Subject Matter Experts to ensure documentation updates are approved.

· Collaborate with all the site functional areas and other support teams.

Experience, Knowledge & Skills

Key Personal Skills

· Networking skills within peer and other work groups across the site.

· Enthusiastic contributor to the creation and development of our site culture.

· Exceptional communication skills and ability to communicate to multiple levels within company.

· Experience with technical writing.

General

Experience in the Pharmaceutical GMP regulated industry desirable.

Excellent verbal and written communication skills.

Ability to work independently and as part of a team in a cross functional collaborative environment.

Experience working with GMP Documentation Management Systems

High level of attention to detail.

Demonstrated ability to manage multiple priorities against ambitious timelines. Strong planning ability.

Strong problem-solving skills and ability to work cross-functionally.

Technical experience

Should be proficient with Microsoft Office tools, (MS WORD/PowerPoint/ /Microsoft)

Experience with SAP/Trackwise/Veeva Quality docs advantageous.

Qualifications & Education

Education requirements

* A minimum of level 6 qualification in a Science, Engineering, or Project Management discipline

Company

i-Pharm Consulting provides Talent Solutions for the global Life Sciences sector.

We are an award-winning international life sciences recruitment company with offices in London, Munich, Frankfurt, Sydney, New York, Charlotte, and Los Angeles. In a highly competitive marketplace, we connect top talent with the very best opportunities.

Since 2008, i-Pharm’s independent, expert, and ethical approach to procuring talent has helped power the pioneering progress made by Pharmaceutical, Biotech and MedTech companies around the world. 

With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.

For candidates, we become “career partners”. We know them as people, not CVs, learning about their aims, motivations and personal situation. We build open dialogue, provide honest advice and offer ongoing support, whether or not we’re currently working with them. ​

As a result, we have supported many specialists in this focused field throughout their careers, helping them plan their path through life sciences by identifying the right roles for them, not just any roles to suit us.

We change the lives and trajectory of our candidates' careers by offering incredible opportunities with the best clients in the sector.

 

Company info
Website
Telephone
+44 (0) 20 3189 2299
Location
52 Bedford Row
London
England
WC1R 4LR
United Kingdom

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