Officer at HEIKAL

Bengaluru, karnataka, India -

Full Time

Start Date

Immediate

Expiry Date

20 Jun, 26

Salary

0.0

Posted On

22 Mar, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

IPQA, API Quality Assurance, cGMP Compliance, QMS, GDP, Internal Audits, Customer Audits, Regulatory Audits, Gap Assessment, Line Clearance, Qualification, Validation, BMR Review, BCR Review, CAPA Effectiveness, Risk Assessment

Industry

Housing and Community Development

Description

Role: IPQA Designation: Officer Job specification: B.Sc./M.Sc. chemistry with less than 2-3 years (Only male candidate) Job description & key skills: Experience in API Quality assurance (especially IPQA) Sl. No Responsibilities 1. Monitoring and ensuring compliance in line with cGMP. 1. Plant rounds and ensure the cGMP compliance according to standard operating procedure in Unit-I and Unit-II 1. Define and implement the overall QA strategic approach to maintain the QMS, GDP & cGMP requirement in the system. 1. Co-ordination with cross functional teams to improve quality systems in the site. 1. Co-ordination for internal audits, customer audits / visit and regulatory audits on the site. 1. Gap assessment of system and resolve with the support of cross functional team. 1. Identify areas for improvement of quality and gain efficiencies. 1. Perform line clearance activities in the manufacturing blocks. 1. Review and Monitoring of qualification and validation activities. 1. Review and approval of Raw material and Packing material request as per the manufacturing requirement. 1. Verification of housekeeping in the manufacturing blocks, Warehouse, Utility areas etc. 1. Coordination for training activities in all manufacturing blocks. 1. Review of executed BMRs and BCRs in the plant. 1. To review the equipment usage logbooks and checklists. 1. Review and monitoring pest control management. 1. Coordinating to CAPA effectiveness verification. 1. Review of Risk assessment. 1. Supporting to audit compliance and verification and follow-up with support functions for activities execution and documents closure 1. Verification of preventive maintenance and calibration status. 1. Issuance of logbooks, Checklists and Protocols as per the request 1. Issuance of straps as per the user request. 1. Preparation and review of APQRs. 1. Attending of Customer related Questionnaires. 1. Preparation and review of Standard Operating Procedures. 1. Responsible for handling any other tasks assigned by the reporting manager and above with prior training on the respective activity.

Responsibilities

The Officer will be responsible for monitoring and ensuring compliance with cGMP standards through plant rounds, defining QA strategy, and coordinating cross-functional teams to maintain the Quality Management System. Key duties include managing audits, performing gap assessments, executing line clearance, and reviewing various quality-related documents and activities.