Supervisor, Quality - Q&V
BaxterAhmedabadUpdate time: July 30,2019
Job Description

Are you looking for a career that matters?

We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.

https://www.youtube.com/watch?v=X0h_0ih8MgQ

  • To prepare, execute, compile  and review all equipment, utility, cleaning, process validation, smoke study and media fill protocols & send it to Department Head for further review.
  • To review process validation & qualification planner.
  • To ensure Material issuance for validations activities and keep Department Head updated.
  • To ensure implementation of validation, qualification activities & inform to higher authority about any deviation.
  • To ensure proper planning with cross functional department to adhere with periodic qualification calendar and completion on time as per the calendar.
  • To ensure sample withdrawal during process validation.
  • To ensure observation sheets for process validation are duly filled & signed.
  • To coordinate among various departments for process validation, qualification activities.
  • To conduct trainings on each protocol before execution of validation and qualification activities with cross functional department and document the same once training is completed.
  • Responsible to initiate the Change Control Note (CCN), Deviations, CAPA & other QMS elements related to validation activities and conducting proper investigation and closure of all these QMS documents.
  • To review the summary and all other validation documents provided for regulatory filing.
  • To review all validation and qualification documents and the periodic validation calendar.
  • Responsible to ensure the execution of validation and qualification activities as per protocol and SOP.
  • Responsible to revise SOP and protocols as per current regulatory guideline or any audit compliance requirement and provide it to Department Head for Review.
  • Responsible for revision of VMP and Site Master file as per regulatory guideline or any audit compliance requirement and provide it to Department Head for Review.
  • To initiate and investigate QMS document related to validation activity and it’s closure on time for all the facilities in this site .
  • To conduct entire validation activity on any of the facility in this site.
  • Responsible to carry out any other qualification  and validation related functions assigned time to time by the reporting authority.
  • Responsible to participate in any external inspection .
  • To intimate Production, Planning & Availability (PPA) in advance for process validation & qualification activities.
  • To keep the team updated about all upcoming new validation activities.
  • To co-ordinate with projects effectively for new equipment and utility qualification.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
                                                                                                                                                               
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Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

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