Posted:3 weeks ago|
Platform:
Work from Office
Full Time
Job Title: QA Assistant / Executive - API Industry
Location: Kakinada, AP
Company: Lyfius Pharma
About Lyfius Pharma is 100% subsidiary of Aurobindo Pharma. Its largest API Unit of Aurobindo. Lyfius spread across 236 acres in Kakinada SEZ and it is second largest API manufacturing facility in ASIA.
Qualification: M Sc / B Sc/ B Pharm
Experience: 2 to 10 Years
Job responsibilities:
Quality Management System QMS
Handling & Responsible for:
Change Control,
Deviation,
Out of Specification,
Market Complaint,
Corrective and Preventive Action (CAPA)
Annual Product Quality Review.
Audit Compliance Report Preparation.
Document Controller
All document Issue, Review & Retrieval
COA preparation
BMR & BPR Preparation & Review
Specification, Method of Analysis & Protocol & Report preparation for Finished product, Intermediate product, In-process, Raw material, Packing material.
Standard Operating Procedure (SOP) Preparation
Site Master Plan & Validation Master Plan Preparation
Technical Data Package (Tech Pack), Formula Master Preparation.
All Declaration Preparation for regulatory submission,
Customer Free Sample, Vendor Sample and Customer Query Related work.
Policies & system procedures preparation.
External Manufacturing & Toller documentation Control & Follow-up.
Training Calendar preparation and control.
Qualification / Calibration / Validation
Responsible for all Calibration activity Internal & External and maintained the record.
Responsible for Equipment Qualification & Documentation control
Vendor Qualification and regular follow up for updated documentation by the supplier,
Process Validation Protocol & Report Preparation
Cleaning Validation Protocol & Report Preparation
Analytical Method Validation Protocol & Report Preparation
IPQA
Issue and control of SOPs, BMRs, BPRs, BCRs and also finished product label/product container seals /sealing of the containers as the part of IPQA activities.
Review BMRs, BCRs and analysis records before release of API.
Perform sampling of APIs, maintain its records and ensure the cleaning of sampling tools.
Provide line clearance at the time of product changes over.
Perform the documentation control activity at site.
Monitor/Maintain/Review of Records and Handling of controlled/Retained samples of Intermediates/Finished API.
Apitoria Pharma
Upload Resume
Drag or click to upload
Your data is secure with us, protected by advanced encryption.
Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.
We have sent an OTP to your contact. Please enter it below to verify.
Instantly access job listings, apply easily, and track applications.
3.0 - 8.0 Lacs P.A.
Mohali, Chandigarh
8.0 - 15.0 Lacs P.A.
2.0 - 4.0 Lacs P.A.
Ankleshwar
4.0 - 6.0 Lacs P.A.
0.8 - 1.0 Lacs P.A.
New Delhi, Gurugram, Delhi / NCR
3.0 - 8.0 Lacs P.A.
Dhule, Chalisgaon
5.0 - 10.0 Lacs P.A.
4.0 - 8.0 Lacs P.A.
Faridabad, Gurugram, Sohna
6.5 - 8.0 Lacs P.A.
3.0 - 7.0 Lacs P.A.
