Student Regulatory Affairs Assistant 526

Student Regulatory Affairs Assistant 526

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Onsite

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Regulatory Affairs

Study contract

About the job

ProductLife Group are looking for a skilled and enthusiastic student living in Denmark, who can work approximately fifteen (15) hours per week from the client’s offices in Valby. The activities to be provided by students will be varied. Full training will be given. The activities may include the tasks outlined below:

Responsabilities

• RA archive management in the headquarter in Valby in line with compliance (GXP, internal SOPs and company Policies)
• Receiving incoming documents, indexing those and electronic registering/archiving, physical filing of paper docs
• On request (in case of inspections or audits), locate archived documents and provide those to the requesting department
• Once those are returned, index and archive them again
• Clean documents in line with the documentation retention limits
• Special projects in case the company sells products, all relevant RA docs need to be sent to buyer and removed from archive
• And vice versa, if the company buys product, archive the incoming docs
• Order boxes, binders, stickers, labels, pallets etc. needed for delivering to archiving tasks
• Managing incoming post
• Assist in the preparation of Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs)
• Assist in the management of ProductLife Quality Management System
• To participate in training as required for ProductLife staff
• To comply with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives.

Profile

• Currently studying for a bachelor or master’s degree related with Pharmacy, Pharmaceutical Design, Biology, Chemistry, etc.
• Excellent organizational and interpersonal skills
• Ability to work well within a team
• Process orientated with good attention to detail
• Effective oral and written communication skills
• Good computer skills and the ability to learn appropriate software
• Good understanding of regulatory tracking database software, eDMS, MS Word, MS Excel
• Good English language and grammar skills (written fluency a must, verbal fluency preferred), at least one Nordic language mastered is a plus