Quality Compliance Documentation Specialist İş İlanı
İşveren Hakkında
QUALIFICATIONS AND JOB DESCRIPTION
GENEL NİTELİKLER
We are looking for Quality Compliance Documentation Specialist who will be responsible for the following processes:
Main Responsibilities
- To assure that the requirements related to process and product quality as well as compliance are fulfilled as stated in our company’s quality standards and Ministry of Health requirements and to assure that Quality Unit of site takes a position at the top of the company with regard to compliance, service quality and performance criteria.
- To ensure GMP and GDP requirements defined by authorities are completely and effectively implemented.
· Creating SAP master inspection plans and certificate profiles of Raw Materials, Packaging and Finished products,
· To follow the pharmacopoeia updates, to apply the relevant revisions.
· To prepare analysis certificate for requests of submission (local or export), purchasing and other departments.
· To prepare and control analytical methods, specifications, general methods and worksheet, to followup distributions.
· Distributing of effective SOP/Instruction/Form to related the departments and archiving the SOP/Instruction/Form after HISTORICAL is stamped on the document.
- Archiving and scanning of batches file in timely manner. Transfering batch files to related link and inform responsible person by e-mail
- Creating purchasing orders and spenditure management for Quality Assurance.
- To send documents and samples by courier to local or external countries.
· To prepare Annual Product Review / Product Quality Review for products manufactured at company and tracking of annual PQR plan.
· Updating the documantiton and records management procedures regarding to Document Management System.
- Management of documentation archive for Quality Assurance.
- Management of the rooms of the Ministry Samples including cleaning review and documentation for destraction of the samples in accordance with the procedure.
- To provide SOP/Instructions trainings regarding to document management and annual refreshment training of GMP / Data Integrity.
- To initiate and investigate deviation, quality event or CAPA related with Documentation Management in QMEX.
Main Requirements
- Min. 2years experience in Quality Assurance or related departments regarding to Document Management.
- Pre-Intermediate or Intermediate level of English is plus to prefer.
- Good knowledge of SAP, QMEX and Office Programmes.
- Good at Time Management, Communication and focusing details.
- Having a good level of Quality Mindse
