Overview
Quality Assurance Manager Jobs in Gazipur Sadar Upazila, Dhaka, Bangladesh at World Chemical Industry Ltd.
Title: Quality Assurance Manager
Company: World Chemical Industry Ltd.
Location: Gazipur Sadar Upazila, Dhaka, Bangladesh
Job Title: Quality Assurance (QA) Manager
Company: World API Chemical Industry Ltd.
Location: Joydebpur Chowrasta
Department: Quality Assurance
Reports To: Managing Director / Head of Operations
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Job Summary
The QA Manager is responsible for establishing, implementing, and maintaining a robust Quality Management System (QMS) to ensure that all manufactured Paracetamol BP API complies with regulatory standards, pharmacopeial requirements, and customer specifications. The role ensures full compliance with GMP, documentation integrity, and continuous quality improvement across all operations.
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Key Responsibilities
1. Quality Management System (QMS)
* Develop, implement, and maintain QMS in compliance with GMP, WHO, and regulatory guidelines.
* Ensure proper documentation, control, and archival of SOPs, policies, and records.
* Lead continuous improvement initiatives to enhance product quality and compliance.
2. GMP Compliance & Regulatory Affairs
* Ensure compliance with current Good Manufacturing Practices (cGMP).
* Prepare for and manage regulatory inspections and audits (local and international).
* Ensure adherence to BP (British Pharmacopoeia) standards for Paracetamol API.
3. Documentation & Data Integrity
* Review and approve batch manufacturing records (BMR), batch packing records (BPR), and analytical reports.
* Ensure ALCOA+ principles (data integrity) are strictly followed.
* Oversee deviation reports, change controls, and CAPA (Corrective and Preventive Actions).
4. Quality Control Oversight
* Coordinate with QC department to ensure proper testing and release of raw materials, intermediates, and finished API.
* Approve specifications, test methods, and validation protocols.
5. Validation & Qualification
* Oversee process validation, cleaning validation, and equipment qualification (IQ/OQ/PQ).
* Ensure validation activities are documented and compliant with regulatory standards.
6. Audit Management
* Conduct internal audits and supplier audits.
* Handle external audits by regulatory authorities and customers.
* Ensure timely closure of audit observations.
7. Training & Team Management
* Develop and implement training programs for QA and production staff.
* Build a strong quality culture within the organization.
* Supervise QA team performance and development.
8. Risk Management
* Identify quality risks and implement mitigation strategies.
* Ensure product safety, consistency, and traceability.
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Qualifications & Requirements
* Bachelor’s or Master’s degree in Pharmacy, Chemistry, Chemical Engineering, or related field.
* Minimum 5–8 years of experience in pharmaceutical API manufacturing, with at least 2–3 years in a managerial QA role.
* Strong knowledge of GMP, WHO guidelines, and BP standards.
* Experience in Paracetamol API manufacturing is highly preferred.
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Key Skills
* Strong leadership and team management
* Excellent documentation and analytical skills
* In-depth knowledge of regulatory compliance
* Attention to detail and problem-solving ability
* Effective communication and audit handling skills
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Key Performance Indicators (KPIs)
* Audit compliance score
* Deviation closure time
* CAPA effectiveness
* Batch rejection rate
* Regulatory inspection outcomes
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Working Conditions
* Full-time role based in manufacturing facility
* May require extended hours during audits or regulatory inspections
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Additional Notes
* The QA Manager plays a critical role in ensuring that all Paracetamol BP API products meet international quality standards and are safe for pharmaceutical use.
* The position requires a high level of integrity, accountability, and commitment to quality excellence.
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