Associate Manager Validation

Posted 24 Jan 2023

Bangalore, Karnataka - India

Req Id 260494

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.


 

  1. Identifying, Planning and implementation of validation requirements in a cGMP Environment, including cleanroom, equipment, instruments and manufacturing/testing processes, in a  Green Field Pharma facility, Shall have experience in validation as per ISPE C&Q guidelines. Should have experience in managing team.
  2. Conversant with QC lab test methods like filter integrity testing, Endotoxin (LAL), flow/delta p,and  oxidizable substances testing.
  3. Have expertise in environmental monitoring, water monitoring in cleanroon and have ability to trouble shoot the excursions.Have experience in organism identification activities. Have expertise in trending EM results and RCA /CA .
  4. Conversant with Risk Management techniques.
  5. Experienced in Microbiology techniques.
  6. Have expertise in managing shelf life studies (accelerated and routine).
  7. Have experience in building quality related infrastructure,& instruments including preparation of URS, System Risk Assessment, and subsequent validation.
  8. Have experience in managing AHU, trouble shooting. Conversant with cleanroom design.
  9. Ensuring the laboratory's Quality Management Systems (QMS) conforms with requirements in the ISO 9001 standard, applicable Group policies, site policies and procedures, and laboratory Quality documents,
  10. Developing quality objectives that are compatible with the context and strategic direction of the organization, and for communicating these quality objectives as well as the Quality Policy to all within the organization
  11. Proactively identifying risks and opportunities through a variety of surveillance activities including trending of non-conformance events, lab walkthroughs, self-inspections and lab records/data review ensure continued suitability, adequacy, effectiveness and alignment of the QMS with the strategic direction of the organization
  12. Communicating and reviewing risks with site and global management to ensure customer, statutory and regulatory requirements are determined, understood and consistently met
  13. Supporting and actively participating in the local implementation of global projects or initiatives, change management related to new and revised services, and communication customer notifications as needed
  14. Supporting EHS and OSHA implementation as needed.
  15. Staying current with standards and procedures, applicable industry regulations and trends.
  16. Shall be a Global team player willing to embrace multi-cultural, multi-lingual and multi-time zone work environment.
  17. Have Excellent networking skills allowing effective interactions and the ability to work collaboratively across all functions with various levels of stakeholders
  18. Have Proven experience with various problem-solving methodologies
  19. Have ability to manage change and implement improvement solutions across cross- functional teams

 

Work Experience

  1. Must have around 10 years experience and at least 3 years worked in Quality Validation role.
  2. Worked in reputed Pharma Industries, preferably good MNC’s. Should have handled projects, and facilities startup.

 


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!


Equal Employment Opportunities

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure

If you are a resident of Colorado or New York City, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

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