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
Positive 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 Improvement

Implementation 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 current 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 an

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