SPS BE Delegate Qualified Person

Location: Town of Belgium

SPS BE Delegate Qualified Person page is loaded## SPS BE Delegate Qualified Person locations:
Hamont-Acheltime type:
Full time posted on:
Posted 5 Days Agojob requisition :
JR31787

To strengthen our team in Hamont-Achel we are recruiting for a
** Delegate Qualified Person**:

Position:
* Act as a delegate QP to ensure that each batch has been manufactured and checked in compliance with the laws in and in accordance with the requirements of the marketing authorization
* Act as a delegate QP by performing batch disposition and subsequent registration of the batch in the release register in line with  Annex 16 to the EU Guide to Good Manufacturing Practice

Title:

Certification by a Qualified Person and Batch Release and Article 48 of Directive 2001/83/EC and Article 52 of Directive 2001/82/EC.
* Oversee the Quality system to fulfil the Batch Disposition task in line with Annex 16 to the EU Guide to Good Manufacturing Practice

Title:

Certification by a Qualified Person and Batch Release and Article 48 of Directive 2001/83/EC and Article 52 of Directive 2001/82/EC
* Evaluate and approve Changes proposed through the Change control system.
* Review and approve final investigation reports on incidents, complaints and investigations
* Participate in the enhancement of the Sharp quality system to assure the right cGMP level for the process and systems at Enestia (Sharp Packaging Solutions) Hamont NV.
* Participate in cGMP improvement activities.
* Ensuring timely and adequate batch disposition decisions
* Participate in projects and contribute to: project execution, validation activities and strategy, compliance to existing legislation or customer requirements and correct implementation of the project in the production environment.
* Provide training to other employees by demonstration, repetition, modelling, large group training, etc.
* Assist in controlling the correct working of the quality management system. Oversee the quality system, evaluation and approval of Change requests, CAPA plans and outcome of quality reviews
* Write APR / PQR on a timely basis.* (Delegate)
Responsible pharmacist of Enestia (Sharp)
Belgium N.V. trading as Sharp as in the:  + Royal Decree of 6 June 1960  + Directive 2003/94/EC; 91/412/EC  + Directive 2001/83/EC; 2001/82/EC
* Batch documentation integrity, by means of batch record review, review of analytical records and other relevant batch information
* Key (support) role in client and authority audits of Sharp
* Act as lead auditor during supplier audits

Profile:
* Master degree, industrial pharmacist.
* QP Accreditation, according  + Royal Decree of 6 June 1960  + Directive 2003/94/EC; 91/412/EC  + Directive 2001/83/EC; 2001/82/EC
* Completed with relevant training and courses
* A first experience in a QP role for pharmaceutical manufacturing
* Active in depth knowledge on international cGMP guidelines and pharmaceutical regulations.
* Knowledge on Medical Device regulations
* Ownership* Team player, able to work with all levels in the organization
* High level of integrity
* Think in processes
* Positive mind set / Think in solutions
* Decision maker
* Accurate* Organized work processes / set priorities

Offer:

Sharp Packaging Solutions offers you a versatile and challenging job in a dynamic work environment. We create growth opportunities and, in addition to a competitive salary package, we offer you numerous additional benefits.
* Type of contract: permanent
* Time schedule: full-time
* Regime: day shift

Sharp appreciates your interest but does not accept unsolicited assistance from recruitment agencies for this vacancy. Resumes sent to Sharp by recruitment agencies without a specific assignment from the HR department will be considered the property of Sharp. Unfortunately, in such cases, we cannot pay any fees, even if the candidate is hired by Sharp through this referral or other means.

We kindly request that you do not reproduce this vacancy, in whole or in part, without permission.
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