Document Control Administrator

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.

Major Accountabilities
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 documentation to customer expectations. Maintain accurate control and distribution on all approved 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-organised, 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.
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; Coordinating approvals and attending ECO approval meetings; Implementation of 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 Documentation Supervisor.
9. Ensure continual Quality System compliance by adherence to established and evolving Alcon and Novartis QS requirements.

Position Title

Document Control Administrator

Desired profile

Minimum requirements

Specific Position knowledge/skills/abilities:
Must have strong spelling, grammar, written and verbal communication skills. Must have good PC skills. Detail orientated and organised with a good multitasking ability. An ability to work with various required software systems i.e. JDE, Catsweb, Excel, etc. An ability to learn Quality System requirements and an ability to ensure adherence in Alcon Ireland Documentation Control.

Ideal Background

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).
Job Type

Full Time
Country

Ireland
Work Location

Cork City
Functional Area

Quality
Division

ALCON
Business Unit

QUALITY ASSURANCE AL
Employment Type

Regular
Company/Legal Entity

Alcon Laboratories Ireland Ltd