Expires soon Novartis

Documentation Control Administrator

  • Cork (Cork City)
  • Administration

Job description

Job Description

Administer the Documentation Control and Engineering Change process to regulatory, corporate and facility requirements. Administer the records filing/archiving system to satisfy regulatory, corporate and facility requirements.
1.Maintain facility compliance to internal documentation standards and procedures: Provide direction and guidance to personnel that use the engineering change process and document control process.
2.Maintain a Documentation department that meets regulatory, corporate, facility standards and delivers documetnation to customer expectations: Maintain accurate control and distribution on all aproved and regulated facility required documents, standards and software, both within the Doc. Control area and within Alcon Ireland; Work with internal customers, vendors and other Alcon facilities to ensure documentation control meets their requirements.
3.Ensure the Document Control process projects a well organized, efficient and in-control department: Where problems arise either internal to the Cork Doc. Control process or with other Alcon facility doc. controls, address and ensure effective corrective action; Conduct scheduled controlled document reviews; Administer changes to the corporate custom index; Provide training to personnel within the Document Control department; Help develop systems and procedures and implement document control or engineering change process improvements; Help in providing documentation during FDA inspections and regulatory, corporate audits. providing documentation during FDA inspections and regulatory, corporate audits.
4.Administer records retention system for allocated records to satisfy site needs: Prepare, scan, verify and index documents according to written procedures; Co-ordinate document archiving with affected Departments and effectively index for traceability; Co-ordinate requests for document filing/retrieval with external document storage provider utilizing the systems/SOPs provided.
5.Administer the ECO/DCO/DCM process and ensure effective operation according to procedural requirements. This includes: Controlled number assignment; Reviewing submitted engineering change packages; Co-ordinating approvals and attend ECO approval meetings; Implementation on ERP system; Distribution of documents/software.
6.Maintain daily, weekly, monthly statistical measures to evaluate team performance. Maintain monthly QA measures. Distribute measures on Document Control related plant performance. Co-ordinate and acquire input from contributors to the Monthly Quality Department Report.
7.Represent Documentation on allocated projects: Prepare schedules and reports on project status.
8.Other ad-hoc duties as assigned by the Documenation Supervisor
9.Ensure continual Quality System compliance by adherence to established and evolving Alcon and Novartis QS requirements.

Desired profile

Minimum requirements

Education
Minimum: Leaving Certificate or equivalent
Preferred: Certificate in an administrative or business area.
Alternative combination: With adequate related education, (certificate or better), 1 years experience in an administration role would suffice.

Experience
Minimum: 3 years experience in an administration role.
Preferred: 1+ years document control experience in a regulated environment (medical device or pharmaceutical).

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