JOB TITLE
Assistant Manager I, Quality Compliance
JOB PURPOSE

Generic
Implement Quality Compliance & Regulatory Affairs activities at Ankleshwar site adhering to Zentiva Corporate Quality Policies, Regulatory and HSE guidelines with optimum utilization of resources to ensure consistent valuable quality of products to meet with customers’ requirements, living Group’s Values and Code of Ethics.
REQUIREMENTS

Education / Experience
Education:
Postgraduate in Pharmacy
Experience:
10 years in Pharma industry with awareness of Quality management systems, Analytical testing, Method Development/Validation, Manufacturing activities, Process validation, Qualification, Regulatory requirements.
Technical skills &
Competencies / Language
Knowledge of GMP and regulatory requirements
Expertise in an investigations and CAPA management
Valuable interpersonal skills and able to manage conflicts
Believes and lives in company values
Skilled in teamwork
Able to present complicated technical issues in an easy and understandable manner and obtain appropriate actions




Have global view, able to understand the impact of the decision on other company functions.

KEY ACCOUNTABILITIES

Quality compliance / Quality Management/Continuous ImprovementImplementation of Zentiva Global Quality & Regulatory policies & guidelines, review and approval of GxP Documents e.g. Quality Manual, SOPs, Process Validation reports, Master Batch Records, Finished Product specifications, Master Documents, etc.
Submission to regulatory authorities associated with various regulatory requirements, authoring / or coordinating RA activities for recent registrations / licenses, post approval changes, renewals, GMP Certification applications, annual reports and line extensions to meet requirements.
Coordinating and contributing to responses to Agency queries and performing quality review of regulatory submissions.
Coordination for cGMP Training activity including training of identified people.
Review and approval of Art

📌 Assistant Manager I, Quality Compliance Ankleshwar
🏢 Zentiva Group
📍 Ankleshwar