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The ACME Laboratories Limited
Head of Quality Assurance, API
Application Deadline: Nov 10, 2024
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Summary
Published: Sep 26, 2024 Vacancy: 6 Gender: Any
Age: Not Specified Career Level: Experienced Professional Experience: 10 Year
Salary: Negotiable Location: Dhaka
Requirements

Education


  • Masters, M. Pharm/MSc. in Chemistry/Applied Chemistry/Biochemistry from reputed university.

Experience


  • 10 Year

Additional Requirements


  • At least 15 years
  • Strong expertise in API and intermediate manufacturing processes, analytical techniques, and quality control methodologies.
  • Exceptional problem-solving and analytical skills, with a systematic approach to decision-making.
  • Experience coordinating with Production, Quality Control, Warehouse, Engineering, and R&D teams to ensure cGMP compliance within the plant.
  • A minimum of 15 years of experience managing large API (multi-purpose) facilities.
  • Proven experience in quality assurance within the API industry, with substantial leadership experience.
  • A successful track record in managing regulatory inspections and audits from stringent authorities (e.g., US FDA, UK MHRA, EU, TGA, PMDA).
Required Skills & Knowledge:
  • In-depth knowledge of current Good Manufacturing Practices (cGMP), regulatory guidelines (FDA, EMA, etc.), and Quality Management Systems.
  • Excellent leadership and people management abilities, with a talent for inspiring and motivating teams to achieve shared quality objectives.
  • Strong verbal and written communication skills, with the ability to engage confidently with both internal and external stakeholders.

Skills



Responsibilities & Context

  • ACME Laboratories Limited, a leading publicly listed pharmaceutical company, holds a prominent position in both domestic and international markets. To support our business growth and meet evolving needs, we are seeking a highly competent, enthusiastic, energetic, innovative, and qualified professional for the role of Head of Quality Assurance.
  • Job Type: Contractual (initially for two years, with the possibility of extension based on mutual agreement).
  • Job Overview: Responsible for overseeing all Quality Assurance activities.
  • Reports to: Director, API.
  • Key Responsibilities:
  • Develop and implement a comprehensive quality assurance strategy and roadmap that aligns with business goals and regulatory standards.
  • Lead and manage a team of quality assurance professionals, providing guidance, mentorship, and performance evaluations.
  • Establish and maintain robust quality management systems, processes, and procedures to ensure compliance with relevant regulations, guidelines, and standards.
  • Collaborate with cross-functional teams including R&D, manufacturing, regulatory affairs, and supply chain to integrate quality standards throughout the product lifecycle.
  • Conduct risk assessments and audits to identify potential quality issues, deviations, or non-conformities, and implement corrective and preventive actions as needed.
  • Stay current with regulatory requirements (e.g., ICH Q7) and industry trends to drive continuous process improvement and innovation.
  • Promote a culture of quality and continuous improvement by organizing training programs, workshops, and knowledge-sharing initiatives.
  • Act as the primary point of contact for quality-related matters during regulatory inspections, audits, and customer inquiries.


Compensation & Other Benefits
  • Salary Review: Yearly
  • Festival Bonus: 2

Work Place

Work from Office

Employment Status

Type: Full Time/Permanent

Shift: Day Shift

Job Location

Dhaka

Read Before Apply

Candidate should be willing to relocate to Bangladesh (For Overseas Applicant) and meeting all the requirements are highly encourage to apply

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Company Information
Company Name: The ACME Laboratories Limited

Address: Court de la ACME 1/4, Kallayanpur, Mirpur Road, Dhaka 1207, Bangladesh.


Business Type:

We are currently producing more than 800 products in different dosage forms covering broader therapeutic categories which include anti-infective, cardiovascular, antidiabetics, gastrointestinal, CNS, respiratory disease, hormones & steroids etc. among many others.
The success in local market prompted us to explore the international market and over the years we gained a firm presence in South East Asia, Africa and Central America and continuously discovering new horizons to improve the quality of life for patients, to further the success of our customers and to help meet global challenges. Through the outstanding knowledge, professionalism and commitment of more than 7000 employees, we are consistently building upon our facilities, capabilities and also portfolio to meet the growing health care needs.

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