GMP Compliance Manager İş İlanı
İşveren Hakkında
QUALIFICATIONS AND JOB DESCRIPTION
YOUR TASKS AND RESPONSIBILITIES
- To take responsibilities of GMP Compliance activities for Change Management. Perform first quality evaluation of all local changes and, to carry-out GMP evaluation of actions, to follow up the completion of actions and implementation changes according to GMP rules and on time.
- To be primary contact to represent Bayer Turk Commercial Quality for change management process at Bayer Global & Bayer Turkey. Being ownership & taking direct responsibility of local change management system and software, and also to work as Local Change Manager & Local Key User responsible of Global Pharma Change Management System (BASICS) for import PH products
- To perform quality assessment and to follow up adaptation of local process in accordance with requirements of global changes throughout Bayer Commercial organization. Manage adaptation / implementation of Product changes into the quality management system of the Commercial organization
- To follow-up closely CMO related changes and perform assessment of possible effect of the changes to the Quality Management System / Products considering with Bayer procedures, laws, regulations and current status. Create local and global awareness about upcoming changes to ensure proper escalation and readiness is in place.
- Work closely together with Quality Business Partners to follow-up adaptation/implementation of Product changes at CMOs.
- To take active role to ensure Regulatory Compliance for all Bayer Turk products.
- To ensure effective self-inspection program is operated. To ensure the Annual Plan of Self Inspections are prepared and carried out accordingly. To follow up the closure of corrective and preventive actions (CAPAs) on time. To take responsibilities of GMP Compliance activities for GMP Audits such as A&I, MoH, PIC etc. To take direct responsibility of keeping Quality Manual up-to-date. To manage GMP related Risk Assessment Process.
- To follow up stability studies for hormone product which was manufactured in SC Istanbul until end of their completion period.
WHO YOU ARE
- University degree in pharmacy, biochemistry, chemistry, chemical engineering.
- At least 5 years of relevant experience in Pharmaceutical Manufacturing and Quality Management.
- Knowledge, practical application and understanding of the sciences/quality assurance are required to perform the functions of this position, including problem solving, troubleshooting, and follow-up skills used in a pharmaceutical/GMP environment.
- Demonstrated ability to collaborate with others in cross-functional settings required.
- Demonstrated ability to communicate positively with personnel at all levels (verbally and in writing) is required.
- Demonstrated ability to take initiative and a willingness to learn and stay abreast of current standards required.
- Must have good personal computer skills. Experience using Microsoft Office software is preferred.
- Strong cross-functional and intercultural skills.
- Excellent command of both written and spoken English; Turkish is required
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