Cqh India and Ccqh South Asia

**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.**

**CQH India and CCQH South Asia**

**POSITION PURPOSE**:
This position will be responsible for commercial Quality as CQH India and as Cluster Quality Head - South Asia for the countries Sri Lanka, Bangladesh and Pakistan.

**YOUR TASKS AND RESPONSIBILITIES**:

- Set up and maintenance of Local Quality Management System
- Quality Overview on Supply Chain & Logistics of assigned CFAs
- Quality Oversight on Radiology business and compliance on to the Distribution and Service function based in India
- Execution of Deviaiton, QMR, Self-assessment and Change and CAPA processes to ensure QA compliance in the area of responsibility

GDP - regional scope - India / Sri Lanka / Bangladesh / Pakistan

GDP (GMP) - local scope - India

GDP - global - QA topics / interaction with corporate and global functions
- Implementation of all GDP related requirements defined in Bayer QMS as well as local law that is applicable for distribution of final prodcuts in India including Radiology (Medical Devices)
- Review and check applicability of global Directives and wherever required transfer to local SOPs and Quality Assurance documentation
- Execute & Maintain Quality Assurance Agreements with Bayer legal entities, Legal Manufacturers, distributors and sub distributors (scope GDP and non-routine repackaging)
- Handling of customer complaints, Deviations and CAPA in current tools - Oversight on Repackaging operations to comply the law of land and Bayer regulation
- Quality inspection of finished goods & ensure un-interrupted Supply of Finished Goods meeting quality standards
- Quality Oversight and compliance on to the Distribution and Service function (Bayer intern asnd Third Party) based in India
- GDP audits at Distributors & Sub-Distributors to ensure GDP, Regulatory & Safety compliance
- Shooting the trouble at Distribution function related to Quality aspects and Monitoring Temperature throughout all channel of storage & distribution
- QA topic Training & refresher Training to educate and update India Bayer organization and Third Parties (Distributors, Service Provider) to ensure Bayer quality requirements and standards are implemented
- Quality Oversight on Radiology Medical Devices Business
- Monitoring & verification of disinfection activities at CFA' level for Sterile Medical devices including market return of devices.
- Ensure un-interrupted Supply of Finished Goods
- Ensure current qualification of QA staff repoting to CQH / CCQH
- Primary contact for regulatory agencies regarding quality related issues & provides local support for Health authority inspections and representation
- Implementation on notification received from CDSCO - Ministry of Health & Family Welfare for devices imported products.
- Development and implementation of Medical Device Quality System standards and processes as part of QMS

**WHO YOU ARE**:

- Graduate in Pharmacy with atleast of 10 years of experience in quality functions
- Most Senior Quality person with experience in international pharmaceutical company
- Strong pharmaceutical and regulatory background (Compliance)
- Project management skills
- Strong cross functional skills
- Excellent communication and negotiation skills
- Organizational and administrative skills
- Very good written and spoken English skills

**Bayer does not charge any fees whatsoever for recruitment process. Please do not entertain such demand for payment by any individuals / entities in connection with recruitment with any Bayer Group entity(ies) worldwide under any pretext.**

**YOUR APPLICATION**

**Location**:

- India : Maharashtra : Thane**Division**:

- Pharmaceuticals**Reference Code**:

- 783984**Contact Us**
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- +91-XXXXXXXXXX