Assistant Manager Quality at The businesses of Merck KGaA, Darmstadt, Germany

Mumbai, maharashtra, India -

Full Time

Start Date

Immediate

Expiry Date

02 May, 26

Salary

0.0

Posted On

01 Feb, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management Systems, ISO 9001, Good Distribution Practices, Regulatory Compliance, Standard Operating Procedures, Cold Chain Validation, Internal Audits, Change Control, Deviation Management, CAPA Investigations, Customer Complaint Investigation, Training Programs, Continuous Improvement, Risk Management, Analytical Thinking, Problem Solving

Industry

Pharmaceutical Manufacturing

Description

Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us. Your Role Responsible for implementation and maintenance of Quality Management Systems and ensuring compliance with ISO 9001 QMS requirements, Good Distribution Practices and regulatory requirements as applicable, and company Policies and SOPs related to Storage and Distribution of products at Mumbai and Bangalore Distribution centers. Strong co-ordination with cross-functional departments to maintain high-quality standards in storage and distribution.” Implement, and maintain ISO 9001:2015 Quality Management Systems (QMS). Ensure compliance with GDP (Good Distribution Practices) and regulatory requirements as applicable to business. Handle Distribution site inspections and audits; prepare documentation and respond to findings. Prepare and review Standard Operating Procedures (SOPs) related to Storage and Distribution Prepare and review cold chain validation protocols and reports. Conduct internal audits/self-inspections, and supplier/vendor audits. Manage Change Control, Deviation and CAPA investigations. Investigate customer complaints and product returns Oversee training programs for Distribution staff on quality-related matters. Support continuous improvement initiatives and risk management strategies. Ensure good documentation practices and data integrity are maintained storage and distribution Who you are Education: B. Sc., M. Sc., B. Pharm., M. Pharm Experience: Minimum 9–10 years in pharmaceutical QA with atleast 3 - 4 years in a supervisory role. Experience in FMCG/Pharmaceutical companies desired Good leadership and team management skills. Analytical thinking and problem-solving abilities. Good written and verbal communication. Proficient in QMS tools (e.g., risk assessment, root cause analysis, six sigma concepts). Experience with SAP / ERP system, or other digital QA tools is an advantage. Location & Travel Job location: Patalaganga, Maharashtra; should be willing to relocate if required. Travel: Moderate travel to company’s other locations as and when required What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of our diverse team!

Responsibilities

Responsible for the implementation and maintenance of Quality Management Systems, ensuring compliance with ISO 9001 and Good Distribution Practices. This includes handling inspections, audits, and managing quality-related training programs.