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
* Good 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.
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 new 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.