Manage DCC (document control center) operation by processing and retrieving documents and sending
to internal or archiving * Lead special projects (e.g., documentation remediation) in collaboration with team members; identify
opportunities for process improvement including developing and proposing solutions, and proposing new processes and system enhancement * Ensure compliance with internal procedures, coordinate and perform incorporation of approved changes
to documentation (e.g. verify track changes to update drawing documents) and verify correct implementation to comply with EW and Local Regulatory Requirements * Responsible for final documentation review by processing, reviewing, and releasing product at
distribution center and RLRP (right label right product) * Create labeling contents including add-on label, IFU and preprinted artwork with collaborating with
vendors and internal stakeholders * Evaluate changes proposed by initiators and provide feedback
Requirement:
Good computer skills in usage of MS Office Suite
Excellent written and verbal communication skills and interpersonal relationship skills
Good problem-solving and critical thinking skills
Good ability to read, write and speak English
Solid knowledge and understanding of Edwards policies, procedures, and regulatory (e.g., medical, pharmaceutical) guidelines relevant to documentation
Solid understanding of medical device documentation development activities
Ability to manage confidential information with discretion
Contributes to the completion of more complex organizational projects and goals
Errors in judgment or failure to achieve results would normally require a moderate expenditure of resources to rectify
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span
To apply online please click the 'Apply' button below. For email a detailed resume in Word format to Caryn Lee.
For further discussion about this role, please find contact details of Caryn Lee as below: Email: general5@recruitexpress.com.my Tel: 03-27138830 *All information will be treated with strictest confidence. We regret that only short-listed applicants will be notified.
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