Title: Manager – Quality Operations
Company Name: EREBA Capsules Ltd.
Vacancy: --
Age: Na
Job Location: Mymensingh (Bhaluka)
Salary: --
Experience:
Experience: At least 8 year(s)
The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies
Minimum 8–12 years of experience in pharmaceutical Quality Operations.
At least 6 years in a senior managerial/leadership role in QA/QC.
Experience in regulatory inspections and audits is highly preferred.
Job Location: EREBA Capsules plant, Bhaluka, Mymensingh, Frequent field visit with sales team will be required.
Responsibilities
Implement and monitor Quality Assurance systems to ensure full compliance with regulatory requirements.
Establish and maintain Quality Risk Management (QRM) systems to control operational and compliance risks.
Ensure compliance with cGMP, company SOPs, Health & Safety policies, and regulatory standards.
Lead supplier, subcontractor, and self-inspection audits to meet cGMP requirements.
Review, approve, and manage SOPs, Technical Agreements, and Quality Agreements.
Ensure proper investigation, documentation, and corrective action for deviations, errors, complaints, failures, and adverse events.
Maintain Data Integrity and Good Documentation Practices (GDP) across the site.
Drive continuous improvement and achieve Quality KPIs aligned with company objectives.
Develop, guide, and strengthen the Quality team structure, ensuring competency and performance.
Promote and establish a strong Quality Culture and Quality Behavior at the plant level.
Any other project (if any) as and when required by the management.
Salary Range
Attractive salary package will be given to deserving candidates.