Head of Quality Assurance, API

Job Description

Title: Head of Quality Assurance, API

Company Name: The ACME Laboratories Limited

Vacancy: --

Age: Na

Job Location: Dhaka

Salary: --

Experience:

• At least 15 years

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

• At least 15 years

• Strong knowledge of API & Intermediate manufacturing processes, analytical techniques, and quality control methodologies.

• Exceptional problem-solving and analytical abilities, with a systematic approach to decision-making.

• Coordination with Production, Quality Control, Warehouse, Engineering & R&D to ensure cGMP in the Plant.

• Minimum 15 years of experience in handing big API (multi-purpose) facilities.

• Proven experience in quality assurance roles within the API Industry, with strong experience in a leadership position.

• Proven track record in successfully managing regulatory inspections and audits of stringent regulatory authorities (e.g., US FDA, UK MHRA, EU, TGA, PMDA etc.).

• Required Skills & Knowledge

• Deep understanding of current Good Manufacturing Practices (cGMP), regulatory guidelines (FDA, EMA, etc.), and Quality Management Systems.

• Excellent leadership and people management skills, with the ability to inspire and motivate teams toward achieving common quality goals.

• Effective communication skills, both verbal and written, with the ability to interact confidently with internal and external stakeholders.

About the Company

The ACME Laboratories Limited, one of the top ranked and publicly listed pharmaceutical companies of the country enjoying significant coverage in domestic and international market. To cope up with the business growth and to accommodate business requirements, we are looking for competent, enthusiastic, energetic, innovative, qualified and responsible professional as Head of Quality Assurance.

Job Nature Contractual (initially for two years, which can be extended based on both parties mutual understanding).

Job Summary Overall responsibilities for all activities of Quality Assurance.

Reports to: Director, API

Core Responsibilities

• Develop and implement a comprehensive quality assurance strategy and roadmap aligned with business objectives and regulatory standards.
• Lead and manage a team of quality assurance professionals, providing guidance, coaching, and performance evaluations.
• Establish and maintain robust quality management systems, processes, and procedures to ensure compliance with applicable regulations, guidelines, and standards.
• Collaborate closely with cross-functional teams, including R&D, manufacturing, regulatory affairs, and supply chain, to ensure seamless integration of quality standards throughout the product life cycle.
• Conduct risk assessments and audits to identify potential quality issues, deviations, or non-conformities, and implement appropriate corrective and preventive actions.
• Stay abreast of evolving regulatory requirements (i.e., ICH Q7) and industry trends to proactively identify opportunities for process improvement and innovation.
• Foster a culture of quality and continuous improvement by organizing training programs, workshops, and knowledge-sharing initiatives.
• Serve as the primary point of contact for quality-related matters during regulatory inspections, audits, and customer inquiries.

• Competitive & negotiable depending on individual`s competencies (to be paid in USD or equivalent amount in local currency i.e., BDT).

• Company provided basic furnished two-bedroom accommodation including utilities and maintenance.

• Full time car facility including fuel, maintenance and driver.

• Health insurance and Group Life Insurance coverage as per company policy.

• 2 (two) times return Air Ticket per year with 2 weeks paid holiday each time.

• Yearly performance bonus will be given @ 100% of the gross salary based on performance.

• Mobile phone facility.