Process all Change Plan/Requests for creation through the current Document Management System following applicable policies, process and procedures
Perform proofreading of documents and approve submitted to the Documentation Area for further processing
Identify and notify impact of submitted changes to existing procedures
Notify Training area on the document revision/creation or obsoleting
Assign correct and accurate Effective and Periodic Review Dates to QS documents an specifications
Controlled Issuance of paper records (e.g. batch records, logbooks, SOPs) distributed to respective area for execution
Ensure synchronization between multiple document changes and multiple AbbVie sites
Generate status reports to support the business and maintain documentation area metrics
Receive and review global document changes and communicate to applicable SMEs
Maintain, organize, scan and retain documentation in the defined area
Responsible of Record Retention of Quality area documents
Requirements:
Minimum Diploma or degree degree in Business Administration, Secretarial Sciences, Natural Sciences (i.e. Biology, Chemistry), Pharmacy, or Engineering
knowledge of quality / compliance areas as well as regulations and standards affecting APIs and Biologics is desired but not required
Minimum of 2+ years working on Documentation Control related areas in a Compliance (GxP) environment
Industry
Healthcare / Pharmaceutical / Life Science / Medical Device
Specialization
Healthcare - Nurse / Allied Healthcare Healthcare - Pharmaceutical / Life Science / Medical Device / Clinical Research / Regulatory Affairs
Location
West
Employment Type
Contract / Temp Permanent
Salary
Negotiable
If you meet the requirements of this role, please email a detailed resume in Word document to Alvin Lee Peck Keong. CEI Registration No.: R1104781 Email: lifescience@recruitexpress.com.sg
*All information will be treated with strictest confidence. We regret that only short-listed applicants will be notified.