Sr Mgr, Quality Assurance

Posted 4 Days Ago
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Pudupakkam, Marakkanam, Viluppuram, Tamil Nadu, IND
In-Office
Senior level
Healthtech • Pharmaceutical • Telehealth
The Role
Lead and oversee site quality assurance activities including review and approval of validation protocols/reports, master and executed batch record review, cleaning validation, SOPs, investigations and root cause analysis, risk and impact assessments, hold time studies, new product introductions, self-inspections, and commercial dispatch per site schedule.
Summary Generated by Built In

Job Description Summary

This position is responsible for ensuring that the final product observes the company’s quality standards and for the development and implementation of inspection activities, the detection and resolution of problems, and the delivery of quality product.

Job Description

  • Review & approval of Process, Packaging validation, Submission and Engineering batch protocol/ report
  • Master Batch record review (Validation, scale up, Exhibit, Engineering, Commercial)
  • Executed Batch records review (Validation, scale up, Exhibit, Engineering, Commercial)
  • Handling of New Product introduction activity
  • Review & approval of protocols & reports as a part of Investigation
  • Hold time study protocol/ report review & approval
  • Review & approval of cleaning validation protocols, verification protocols and reports.
  • SOP preparation and review
  • Performing & Handling of self-inspection activity.
  • Review & approval of risk assessments & impact assessment
  • Root cause identification and Incident investigation activities
  • Commercial dispatch activity as per site monthly schedule

Skills Required

  • Review and approval of process and packaging validation protocols and reports
  • Master batch record review (validation, scale up, exhibit, engineering, commercial)
  • Executed batch record review (validation, scale up, exhibit, engineering, commercial)
  • Handling new product introduction activities
  • Review and approval of protocols and reports for investigations
  • Hold time study protocol and report review and approval
  • Review and approval of cleaning validation protocols, verification protocols, and reports
  • SOP preparation and review
  • Performing and handling self-inspection activities
  • Review and approval of risk assessments and impact assessments
  • Root cause identification and incident investigation activities
  • Commercial dispatch activity as per site monthly schedule

Endo Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Endo and has not been reviewed or approved by Endo.

  • Fair & Transparent Compensation Pay is considered competitive to good across many roles, with total compensation in commercial positions strengthened by sizable bonus/OTE when targets are met. Subsidiary experiences within the group also point to good compensation, reinforcing a generally positive pay story.
  • Healthcare Strength Core medical, dental, and vision coverage is strong, complemented by virtual care, disease‑management programs, and a health advocate service. Health coverage is described as good, adding perceived value beyond base pay.
  • Retirement Support A 401(k) plan provides a company match up to 4%, supporting employees’ long‑term savings. Current materials outline the matching formula clearly for prospective comparisons.

Endo Insights

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The Company
HQ: İzmir
1,722 Employees
Year Founded: 1997

What We Do

At Endo, our far-reaching vision is simple: to help everyone we serve live their best life. As a specialty pharmaceutical company, we’re motivated by a strong sense of purpose to find better ways to meet unique medical needs. Our global team of passionate employees understands the importance of their work. We’re dedicated to supporting one another as we connect with communities and foster partnerships that elevate quality-of-life and bring the best treatments forward. Our uncompromising commitment results in the delivery of life-enhancing therapies. From intelligent product selection to commercialization, we strive to make a meaningful, tangible impact to help everyone live their best life. Endo has global headquarters in Malvern, Pennsylvania. Community Guidelines: 1. Be respectful. Everyone who visits our page should feel comfortable and respected. 2. If we see a comment that violates anything in the following list, it may be removed. • Comments that use profanity; personally attack or bully another individual; or are off-topic, misleading, factually inaccurate, political, spam, defamatory, discriminatory or promotional. • Comments that are excessively repetitive and/or disruptive to the community. • Comments that promote illegal activity, use copyrights or trademarks or are related to an ongoing legal matter. • Comments that appear to be medical advice. We reserve the right to remove a reply for any reason at any time. 3. Adverse Event Reporting: If we see a post about an adverse event, an Endo representative will need to contact you to find out more information to comply with regulatory guidelines. If you experience a side effect while using an Endo product, please consult your physician or pharmacist immediately. You may also report to the FDA at fda.gov/medwatch or 800-FDA-1088. Replies from other users do not necessarily reflect the views of Endo. We do not endorse content added by other users.

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