Apitoria Walk-in Interview. Apitoria Notification full details below. Interested and eligible candidates can attend Interview on scheduled time and venue.
Vacancy details:
Important Details :
Job Description
Are you looking for an exciting opportunity to grow your career?
Date: 9th March 2025
Time: 9:00 AM – 3:00 PM IST
Venue: Best Western Ramachandra Visakhapatnam 8-8-36, Gajuwaka Main Road | Visakhapatnam | 530026 | Andhra Pradesh
P : 91.891.2579777/ 6669111 | F : 91.891.2548642 |
C : 91.7660011824 | bestwestern.com/in/ramachandra 000-800-440-2474 | bestwesternindia.com (View on map)
Position: Assistant / Executive
Qualification: B. Tech in Mechanical / Electrical/ Instrumentation
Experience: 2 to 7 Years with good track record.
Extraction / API experience:-
Role & responsibilities
1. To procure Raw materials from Ware house
2. Perform the Operations in accordance to the established SOPs and cGMP and capture the data in relevant documents.
3. To maintain for Good documentation practise at work place
4. To ensure the entry of batch related details in ERP.
5. To execute batches every day as per the Production planning schedule.
6. To arrange for Quality testing of in-process, intermediate & finished goods as per SOP.
Job Title: API QA – Assistant / Executive
Location: Kakinada, AP
Company: Qule Pharma
About Qule 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.
Quality Management System
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.
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