Job Description

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.

QA Manager

Position purpose -

This position will primarily be responsible for supporting the Country Quality Head - India in fulfilling his responsibilities to meet Business objectives pertaining to areas of\xe2\x80\x9d:

• Local Quality Management System; implementing Local Quality Management System and compliant Quality process execution
• Quality Overview on Supply Chain & Logistics (e.g. CFAs and transportation)
• Handling of IT tools like Dev@com, AIDa, LifeDoc, CLMS @ DaQS
• Quality Oversight on Radiology business and compliance on to distribution, such as oversight on

• Material handling (re-labeling, incoming good check)
• Technical Service activities
• Execution of Field Safety Correction Actions (FSCA)
• Customer complaints

Major tasks and responsibilities of position

• Preparation of local and regional SOPs (Standard Operating Procedures); transferring global and local requirements and regulation into local QMS / review and check applicability of global quality documents (GSOPs, GOIs).
• Prepare notified body inspections, self-inspection
• Execute & Maintain Quality Assurance Agreements with Legal Manufacturers, Service Providers and internal Bayer legal entities.
• Handling of customer complaints, Deviations using Dev@com tool.
• Repackaging operations to comply with local and Bayer regulation and approved product dossiers (Packaging material artwork review, approval & country specific implementation).
• Quality inspection of finished goods & support un-interrupted Supply of Finished Goods; meeting quality standards.
• Quality Oversight and compliance on to the Distribution function.
• GDP audits at Service Provider to ensure GDP, Regulatory & Safety compliance.
• Monitoring Temperature throughout all channel of storage & distribution.
• Training & refresher Training to educate and update Bayer staff as well as Distributors, Service engineers on GDP and Bayer quality requirements.
• Quality Oversight on Radiology Medical Devices Business

Value added to the success of the company - what are the main objectives of the function?

• Un-interrupted Supply of Finished Goods
• Quality compliance

Work relations

Internal:

• Country Quality Head
• Procurement, SCM, Sales Representatives, PV, Legal
• Sales and Marketing department for discussing the Launch of new products
• Business development for launch of new products
• IT functions for generation, maintenance & retrieval of technical and commercial data in IT systems
• RAD Service Engineers

External:

• Third Party - Service Provider -
• Notified Body Inspectors - MD certification process
• Customers - Handling & interaction on customer complaints and queries
• Work relations

Qualification

• Graduate in natural science, preferable pharmaceutical chemist (with appropriate experience in pharmaceutical industry with focus on quality and / or commercial activities
• Strong pharmaceutical and regulatory background (GMP / GDP Compliance)
• Project management skills
• Strong cross functional skills
• Excellent communication and negotiation skills
• Organizational and administrative skills
• Very good 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.

Please don\'t rely upon any unsolicited email from email addresses not ending with domain name \xe2\x80\x9cbayer.com\xe2\x80\x9d or job advertisements referring you to an email address that does not end with \xe2\x80\x9cbayer.com\xe2\x80\x9d.
YOUR APPLICATION

Bayer is an equal opportunity employer that strongly values fairness and respect at work. We welcome applications from all individuals, regardless of race, religion, gender, age, physical characteristics, disability, sexual orientation etc. We are committed to treating all applicants fairly and avoiding discrimination.

Location: India : Maharashtra : Thane
Division: Pharmaceuticals
Reference Code: 789432
Contact Us
+ 022-25311234

Bayer