Ad-din Pharmaceuticals Ltd Logo
Ad-din Pharmaceuticals Ltd
Asst. Manager/Manager (QA), Sterile
Application Deadline: Jan 03, 2025
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Summary
Published: Nov 19, 2024 Vacancy: Not Specified Gender: Any
Age: Not Specified Career Level: Expert Level Experience: 5 Year
Salary: Negotiable Location: Jessore
Requirements

Education


  • M.Pharm/B.Pharm from any reputed university with sound academic records

Experience


  • 5 Year

Additional Requirements


  • Minimum 5 years of working experience in a pharmaceutical company, particularly in the sterile area, with a proven track record of success in ensuring compliance with quality standards and operational efficiency.
  • Strong work ethic with a high level of self-motivation, honesty, sincerity, and the ability to work independently while adhering to company policies and guidelines.
  • Proficiency in computer skills, including experience with Microsoft Office, internet navigation, and email communication, enabling efficient documentation, reporting, and communication.

Responsibilities & Context

  • Lead the Development, Implementation, and Maintenance of the Quality Management System (QMS) for the new sterile injectable and ophthalmic plant to ensure effective quality control throughout the plant's lifecycle.
  • Ensure Compliance with cGMP, Regulatory Guidelines, and International Standards during the establishment and operation of the sterile plant, ensuring that all processes meet the required regulatory and quality benchmarks.
  • Oversee the Validation and Qualification of sterile production processes, equipment, and facilities to guarantee their suitability for intended use and regulatory compliance.
  • Coordinate and Conduct Internal Audits, Risk Assessments, and Root Cause Analyses to identify areas for continuous improvement in quality systems and processes.
  • Lead Investigations of Deviations, CAPAs (Corrective and Preventive Actions), and Quality Incidents, providing solutions to mitigate risks and prevent recurrence.
  • Collaborate with Regulatory Bodies and Internal Teams to prepare for successful regulatory inspections and approvals, ensuring that the plant meets all necessary standards.
  • Ensure Accurate and Timely Documentation of all activities related to the new sterile plant project, maintaining comprehensive records for future reference and regulatory purposes.
  • Identify and Resolve Technical and Operational Issues to ensure smooth project execution, keeping the plant development on track and addressing any obstacles promptly.


Compensation & Other Benefits
  • Medical allowance
  • Provident fund
  • Gratuity
  • Salary Review: Yearly
  • Festival Bonus: 2

Work Place

Work from Office

Employment Status

Type: Full Time/Permanent

Shift: Day Shift

Job Location

Jessore

Apply Now
Company Information
Company Name: Ad-din Pharmaceuticals Ltd

Address: Head Office: 2 Bara Maghbazar, Dhaka 1217


Business Type:

Pharmaceuticals

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