Manager - Quality Assurance

Job Description

Title: Manager - Quality Assurance

Company Name: Kalyar Replica Limited

Vacancy: --

Location: Gazipur (Gazipur Sadar)

Minimum Salary: Negotiable

Experience:
∎ 10 to 12 years
∎ The applicants should have experience in the following business area(s):Design/Printing/Publishing, Packaging Industry

Published: 8 Apr 2025

Education:
∎ Bachelor of Pharmacy (B.Pharm), Master of Pharmacy (M.Pharm), Master of Science (MSc)

Requirements:

Additional Requirements:
∎ Well conversant in English & Bangla with strong analytical skills is a requirement.
∎ Should be self-driven, result oriented, having ‘can do’ attitude and ability to work with minimal supervision.
∎ Minimum 10-12 years of relevant working experience is required.
∎ Preferred Industry Experience: Pharmaceutical or reputed packaging industries.
∎ Experience with External Audits (especially EU Audit) is preferable.
∎ Extensive knowledge of US and EU cGMP is preferable.
∎ Ability to move about the facility.
∎ Proactive attitude and willingness to learn and grow.
∎ Ability to lead teams, coordinate with departments.
∎ Strong decision-making, problem-solving, and cost control skills.
∎ Well conversant in English & Bangla with strong analytical skills is a requirement.
∎ Should be self-driven, result oriented, having ‘can do’ attitude and ability to work with minimal supervision.
∎ Required Experience
∎ Minimum 10-12 years of relevant working experience is required.
∎ Preferred Industry Experience: Pharmaceutical or reputed packaging industries.
∎ Special Requirements:
∎ Experience with External Audits (especially EU Audit) is preferable.
∎ Extensive knowledge of US and EU cGMP is preferable.
∎ Ability to move about the facility.
∎ Proactive attitude and willingness to learn and grow.
∎ Ability to lead teams, coordinate with departments.
∎ Strong decision-making, problem-solving, and cost control skills.

Responsibilities & Context:
∎ Manage Quality Assurance operations and initiatives related to Quality Systems.
∎ Develop and manage Site Master File, Quality Manual and Validation Master Plan as per regulatory compliance.
∎ Review and approve SOPs, Specifications, Methods etc.
∎ Review batch records and product disposition.
∎ Handle investigations, complaints, deviations, and CAPAs.
∎ Provide input to the development of in terms of regulatory and compliance requirements.
∎ Drive compliance initiatives such as Training Program Enhancements and Quality Documentation System Enhancements.
∎ Develop, maintain, and enhance training programs and systems.
∎ Conduct cGMP training.
∎ Review and approve validation/qualification documentation.
∎ Supervise in process control activities (i.e., line clearance, sampling, and in process checks).
∎ Manage all audits (internal, external, regulatory, client, and supplier).
∎ Oversee supplier management programs and QA agreements with clients and contractors.
∎ Handle license renewals and regulatory filings.
∎ Kalyar Replica Limited (Common Directorship) a well reputed and one of the leading Converter of Flexible Packaging company in Bangladesh is looking for a competent, enthusiastic, energetic, innovative, qualified and responsible professional in its Quality Assurance Department to cope up with the business growth and to accommodate business requirements.
∎ Job Nature: Permanent
∎ Job Location: Nayapara, Mirzapur, Gazipur Sadar, Gazipur.
∎ Core Responsibilities
∎ Manage Quality Assurance operations and initiatives related to Quality Systems.
∎ Develop and manage Site Master File, Quality Manual and Validation Master Plan as per regulatory compliance.
∎ Review and approve SOPs, Specifications, Methods etc.
∎ Review batch records and product disposition.
∎ Handle investigations, complaints, deviations, and CAPAs.
∎ Provide input to the development of in terms of regulatory and compliance requirements.
∎ Drive compliance initiatives such as Training Program Enhancements and Quality Documentation System Enhancements.
∎ Develop, maintain, and enhance training programs and systems.
∎ Conduct cGMP training.
∎ Review and approve validation/qualification documentation.
∎ Supervise in process control activities (i.e., line clearance, sampling, and in process checks).
∎ Manage all audits (internal, external, regulatory, client, and supplier).
∎ Oversee supplier management programs and QA agreements with clients and contractors.
∎ Handle license renewals and regulatory filings.

Skills & Expertise:

Compensation & Other Benefits:
∎ Competitive & negotiable depending on individual's competencies.
∎ Competitive & negotiable depending on individual's competencies.

Employment Status: Full Time

Job Location: Gazipur (Gazipur Sadar)

Read Before Apply:

Candidates who meet all the requirements may send their updated resume to [email protected] mentioning '040325: Manager-Quality Assurance (Kalyar Replica Ltd.) in the email subject line on or before April 16, 2025 (Wednesday).