Quality Assurance Senior Associate

Posted 4 Days Ago
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Pudupakkam, Marakkanam, Viluppuram, Tamil Nadu, IND
In-Office
Senior level
Healthtech • Pharmaceutical • Telehealth
The Role
Plan and execute shopfloor in-process quality assurance (IPQA) activities, authorize line clearances, perform in-process inspections and sampling, manage reserve and stability samples, calibrate IPQC instruments, review batch records, post QA transactions in SAP, conduct maintenance impact assessments, and ensure cGMP and EMS compliance.
Summary Generated by Built In

Job Description Summary

Responsible for planning and Execution of Shopfloor IPQA activities.
Responsible for Authorizing the Line Clearance during the product change over in warehouse and production (manufacturing and packing ).
Responsible for Conducting quality examination in regular intervals by performing in-process checks during the production process.

Job Description

Responsible for planning and Execution of Shopfloor IPQA activities. 

Responsible for Authorizing the Line Clearance during the product change over in warehouse and production (manufacturing and packing ).

Responsible for Conducting quality examination in regular intervals by performing in-process checks during the production process.

esponsible to perform Sampling of intermediates finished drug products, Reserve samples & stability samples from manufacturing and Packing stages and submission to Quality Control unit for testing. 

Responsible for Involvement in hold time study program by performing the sampling and retaining the required sample in controlled storage. Submission of sample to quality control lab on regular intervals as per sampling plan.

Responsible for ensuring the compliance and performing calibration of IPQC-Instrument.

Responsible for to follow the procedures pertaining to the environmental management system and review of EMS alarm history, e-sign with appropriate comments. Report any observation/non-conformance related to the environment management system.

Responsible for Acknowledgement of Maintenance request and performing the impact assessment before closure.

Responsible for performing visual inspection, destruction of reserve sample and Maintenance of reserve sample room.

Responsible for performing product inspection for physical defects as defects as defined frequency in batch record and ensuring the compliance.

Responsible for review batch records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated.

Responsible for release the bulk, Posting sample quantity and other QA associated transaction in SAP.

Responsible for approving or rejecting all procedures impacting on the identity, strength, quality, and purity of the drug product.

Responsible for follow the written procedure applicable to job description. 

Responsible for to adherence of cGMP in all activities performed and responsible for compliance. 

Skills Required

  • Plan and execute shopfloor IPQA/IPQC activities
  • Authorize line clearance during product changeovers in warehouse and production
  • Perform in-process checks and routine quality examinations during production
  • Sample intermediates, finished products, reserve and stability samples and submit to QC
  • Retain and manage reserve samples; maintain reserve sample room and perform destructions as required
  • Participate in hold time studies and follow sampling/retention plans
  • Ensure calibration and maintenance of IPQC instruments
  • Follow environmental management system procedures and review EMS alarm history; e-sign with comments
  • Acknowledge maintenance requests and perform impact assessments prior to closure
  • Perform visual product inspections for physical defects per batch record frequency
  • Review batch records to verify completeness and investigate any errors
  • Release bulk, post sample quantities and other QA transactions in SAP
  • Approve or reject procedures impacting identity, strength, quality, and purity of drug products
  • Adhere to written procedures and ensure cGMP compliance in all activities

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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