Documentation Supervisor – Valeant, Rochester NY

Overview:

JOB ID 6494

Valeant Pharmaceuticals International, Inc. is a diverse and decentralized pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.

Provides oversight and representation for the Documentation Area for Valeant US. Facilitates Document Management process in accordance with the requirements of the Document Management, Training, Change Management; Supplier Management and other relevant Quality Systems.

Responsibilities:

Provides oversight for the Documentation for the Valeant US Region. Coordinates document lifecycle management by processing Document Change Orders, facilitating the review, approval, distribution and monitoring of documentation. GDMS user account set up and maintenance. Interface with IT for GDMS change requests, support script and test solutions before implementation. Oversees all Master Batch Records and Labeling for External Manufacturing goes into Documentum.

Additionally, training documentation that goes into Compliance Wire.

Scope of position: 

Leaderships: Provides oversight for the Documentation Area for Valeant US Region. Includes working with the non-NA regions to assist them in maintaining the Global Documents to keep compliant. Work with IT directly to make modifications in the Documentation system to improve usability. Work with Authors to improve documentation content and provide guidance on best practices. Creates and provides supports to users creating QCRs. Leads projects representing documentation. Project Leadership including experience coordinating the activities of cross functional teams and/or geographically distributed teams. Works continuously with staff to search out new ways to do things better or more efficiently.

Works with EMQA and suppliers to maintain the Master Batch Records and any additions, plus labeling currently used by the External suppliers.

Approve all Regional training materials in Documentum. Working with sites to ensure that each site has adequate training approval system. Work toward ensuring all documents releases have adequate training to ensure competent staff.

Technical: Facilitate Document Management process in accordance with the requirements of the Document Management, Training, Change Management and other relevant Quality Systems. Facilitate awareness of and compliance to the Valeant Quality Management System and applicable FDA and other country regulations plus ISO standards within the scope of the Document Control Management (DCM).

Apply expertise in template and form design, as well as best practices in document design and construction. Train Valeant staff in the company’s document management process. Collaborate with Technical support staff and system user community to understand business requirements and translate them to actionable system requirements. Engage in system design, development, testing and support activities, and participate actively in the change management process, ensuring that established system lifecycle management processes are strictly followed.

Deep understanding of document management practices in medical device and pharmaceutical organizations. Ability to manage multiple priorities and apply sound decision making and problem solving methods. Moderate level competency in Web authoring and publishing using EPRISE.

Compliance: Also participates in FDA inspections as an SME and additionally a war room leader. Lastly, helps to prepare critical responses eg: formats and also tracks responses and attachment preparation.

Works closely with the Bridgewater Document Control Leader.

Key relationships:

Quality and Compliance Leader, Training Leaders, Supply Chain/Supplier Management. VP, Director and other levels.

Qualifications: 
BS or BA degree in a business, technical or scientific discipline required. Certified Auditor would be beneficial

Experience: 

Three or more years of experience in the document management . Strong working knowledge of Document and Records Management and training for ISO and FDA requirements. Significant experience with enterprise applications, such as Document and Content Management tools, and Quality Systems platforms supporting CAPA, Change Control, Compliance Wire Learning Management System.

 

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