Job Description

A global pharmaceutical company has a 6 month contract position available for an RA Assistant.

Key Responsibilities:

• Monitoring of regulatory mailbox and communicates RA submissions and approvals to identified internal stakeholders
• Monitoring of regulatory mailbox for regulatory updates from health authorities to disseminate to regulatory team
• Ordering of certificates and samples required for submission purposes from the CSCC SharePoint
• Processes PO requests on BPCS system
• Maintaining electronic and manual records where applicable
• Converting manual records to electronic records as required
• Track and maintain RA expenses
• Track and maintain payment requests
• Sample Requests xe2x80x93 Co-ordinate requests between local and regional / global stakeholders
• Tracking and maintaining RA contracts for third parties
• Providing support to Finance for RA related payments /expenses
• Support compilation of submissions
• Source documents as required
• Printing and scanning of manual submissions
• General admin support
• Establish and maintain quality management process by maintaining department procedures in updated status.
• Maintaining Data Integrity principle and Good Documentation Practice within area of responsibility.
• Ensure training is completed as planned.
• Attend any quality related training.
• Report any customer complaint to quality within 24 hours of awareness
• Identify any quality related risk in area of responsibility, report to quality, support in risk creation, mitigation
• Identify any quality related incidents in area of responsibility (Planned deviation, Exception, non- conformity, Significant Event) report to quality for assessment and proper documentation
• Support as required in executing Product Actions /recalls. (Applicable only for Quality, regulatory & Supply chain departments)
• Attend Quality Management Review quarterly meetings, when required
• Initiate any change controls relevant to job responsibility, support in change control forum & complete related actions as per timeline.
• Support in audit readiness activities, participate in audits as required

Requirements:

• Food Technology Degree/Diploma
• 1 year completed Internship in R&D
• 1 year experience as an RA Assistant/Administrator.
• Full time office based position

Candidates that meet the criteria may submit their applications via this portal or via vacancy link on www.mnarecruitment.com
Should you receive no feedback within 7 days, please accept your application as unsuccessful.

MNA Recruitment