Associate/Senior Associate, Regulatory Compliance (CAPA Management) - 12 month contract - Cambridge
Star is looking for a contractor to join a biopharmaceutical client on an initial 12 month basis. Our client is a market leader that develops antiviral drugs used to treat a variety of diseases.
We'd like to hear from experienced professionals that can conduct effectiveness checks resulting from CAPAs as well as providing audit coordination resources with typically a BSc/BA or equivalent experience/qualification.
The Associate / Senior Associate's essential Duties & Job Functions
* Provides support for the tracking of Corrective Actions and Preventive Actions (CAPAs) managed by Regulatory Compliance, in line with company policies and procedures.
* Conducts effectiveness checks resulting from CAPAs
* Provides audit coordination resources in support of the International Regulatory Compliance audit programme and team
The Associate / Senior Associate's key responsibilities include:
* Performs data entry of CAPAs in to the CAPA system
* Performs QC of data entered in to the CAPA system
* Works with Regulatory Compliance and cross functionally to assist with the project management of CAPAs
* Obtains source documentation to enable CAPA data entry and confirmation of completion of actions
* Requests review/QC of CAPAs
* Requests missing information and status updates on completion of actions and verification of effectiveness
* Alerts CAPA Owners to pending and overdue CAPAs
* Produces reports from the CAPA system
* Assists in maintaining CAPA report forms and supporting documentation
* Assists with maintaining and developing the CAPA system
* Fulfills the Business Administrator role for the RC CAPA system
* Delivers training on the RC CAPA process and system across the company
* Supports Functional Area users with creating and managing CAPAs in the CAPA system and maintains oversight of their activity
* Establishes methodology to measure the effectiveness of CAPAs, completes the check and documents the outcome
* Creates or may assist in the creation of presentation materials and drafts technical documents as needed
* Manipulates Excel spreadsheets into different sorts and formats and works with Word, Power Point documents as directed by immediate manager
* Gathers, collects, records, tracks and verifies relatively complex data and information from multiple sources
* Gathers, collects, organises and distributes audit related information, including documents, agendas, reports to internal and external people
* Manages provision of training to consultant auditors when required
* Supports Regulatory Compliance during inspections and partner audits when required
Apply for this Associate/Senior Associate, Regulatory Compliance opportunity now via this website, or call Will on 01628 581 240!
Star is a full service resourcing and outsourcing company which resources at all levels for pharmaceutical, medical devices and technology, clinical research and healthcare communications companies in the UK and Ireland on a headcount and outsourced basis. If you haven't heard from us within 7 working days of submitting your application, please assume that you haven't been successful on this occasion. We wish you the best of luck with your job search.