Documentation and Training Controller

3 months ago

Farnham, United Kingdom Boston Scientific Corporation Full time

**Documentation and Training Controller**:

- Remote Eligible: Onsite- Onsite Location(s): Farnham, GB- At Boston Scientific, we draw the strength from the unique talents and abilities inherent in a diverse workforce and we believe that the best and most innovative products come from an inclusive workplace where varied viewpoints are welcomed and encouraged. If you require accommodation during the recruitment process please do not hesitate to contact a member of the Talent Acquisition team for a confidential discussion._

**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance**

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing - whatever your ambitions.

**Broad Function**

To participate in and support activities in the QA Department ensuring all goods manufactured and services provided by the Company meet the quality requirements of the Company, customers and regulatory authorities.

The primary responsibility of the role is to provide support in the management of Quality System Documentation and Training and provide assistance to sites in these activities as required.

The role is also required to provide quality and compliance support for the core quality system processes for the effective functioning of the Pharmaceutical Quality System.

**Principal Responsibilities**
- Support the effective control of Quality System documentation used by BSC within the pharmaceutical quality system, prioritising work load as required
- Operate and support users in the use of the electronic document management system (EDMS)
- Issue controlled copies, batch documentation and other quality system documentation
- Distribute records and manage the archive and destruction of Quality System documentation
- Support the site system administration activities associated with the iQMS
- Responsible for communicating document status to sites and departments which the document control function supports
- Under direction and leadership of the Quality System Manager, ensure compliance in meeting good documentation practice, good manufacturing practice and data integrity requirements for the management of documentation
- Generate documentation and training metrics and provide reports to the Site Leadership Team
- Supervise the secure and controlled retention of documents that require off-site archiving
- To provide documentation control assistance to all levels as appropriate
- Provide support to the site during internal, external and regulatory inspections/audits
- Responsible for the issuance of controlled unique reference numbers to support relevant QMS activities e.g. Document Identification Numbers, Technical Protocols and Reports, etc.
- Ensuring that all interactions and engagements are carried out with the highest ethical and professional standards and that all work accomplished with quality and in accordance with BSC values
- Carry out other ad-hoc requests as required by the line manager
- The above duties and responsibilities are not an exhaustive list and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements._

**Principal Relationships**
- Accountable to - Quality Assurance Manager
- Internal - Liaise with all departments and Boston Scientific sites as necessary.
- External - Maintain external contacts e.g. suppliers, contract facilities and distributors, where appropriate

**Education and Experience required**
- Educated to A-Level (or equivalent) or equivalent working experience
- Experience of working in a regulated industry, ideally a GMP environment
- Computer literate including good knowledge of Word, Excel and Visio.
- Previous experience in working with an EDMS and Microsoft Teams (SharePoint) will be an advantage

**Skills and Attributes required**
- Demonstrated advanced computer skills - Microsoft Office, document formatting preferred.
- Confident communicator with excellent verbal, written and interpersonal skills.
- Able to work under pressure and multi-task with mínimal supervision
- Competent, highly organised individual who pays strict attention to detail

**About us**

**Purpose and Passion - Comprehensive Benefits - Life-Work Integration - Career Growth**

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a differen

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