CQA-compliance
AhmedabadOn-siteMid Level
Applicants who checked fit first are 3.1× more likely to hear back
Before you apply
The post's words + ASAI's dataOn-site in Ahmedabad.
OK with that?Mid Level level, usually 3-5 years.
You have them?No pay range in the post.
Not a repost. 1 of Troikaa Pharmaceuticals's last 23 posts was a repost; 59 of its 62 open roles are here.
11 Quality Assurance Engineer roles posted in Ahmedabad this week, 173 open. See them →
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The job post
320 words · from Troikaa Pharmaceuticals's careers siteSr. No. | Responsibilities |
Internal Audit | |
To carry out the internal audit of different GMP areas at site and inform to user department section HOD for justification/QMS. | |
To follow the internal audit schedule and perform the audit as per SOP. | |
To ensure compliance of training, validation and quality function pertaining to adherence with documents, system and procedure in accordance with the current regulatory expectation. | |
Ensure for procedural compliance across the plant. | |
QMS Compliance | |
Collect, evaluate data and identify the area of improvement, recommend and monitor effectiveness of CAPA. | |
Ensure compliance of trend data of water system, environment monitoring system, change control, deviation, Incident, out of specification, CAPA, etc. | |
To check the investigation of deviation and other non-compliances | |
Review of BMR & other GMP related documents | |
To review of BMR & other GMP related documents and ensure compliance. | |
To review Logs, its execution and compliance. | |
To ensure the compliance of documents issuance ,distribution, retrieval and archival as per procedure | |
Engineering Compliance | |
Review of calibration schedule of Equipments/instruments/ devices, its execution and compliance. | |
Review of Preventive maintenance and calibration schedule & its execution of Equipments/instruments. | |
To ensure well keeping of building maintenance as per respective checklist. | |
To review Engg. Logs, SOPs, Layouts, its execution and compliance. | |
Review and report verification of environment monitoring system (EMS/BMS) and compliance. | |
Validation/qualification documents Compliance | |
Review of validation/qualification documents in view of compliance. | |
To verify Re qualification schedule for timely qualification completion. | |
To verify whether qualification are performed as per defined SOP. | |
Regulatory Compliance | |
To identify gaps between regulatory/compendia requirement and current practice/procedures | |
To provide support to site during regulatory audit. | |
To ensure compliance of training, validation and quality function pertaining to adherence with documents, system and procedure in accordance with the current regulatory expectation. | |
To ensure cGMP and GLP compliance in quality control department. | |
To ensure the compliance of retention sample and stability program as per the procedure. | |
10.0 | Additional responsibilities assigned by head of the department. |
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