Assistant Manager I, Quality Compliance

Requirements

• Education / Experience
• Education:
• Postgraduate in Pharmacy
• 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.
• KEY ACCOUNTABILITIES
• 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.
• Review and approval of Artwork / Labelling.
• Perform the Gap analysis to find out the gaps in existing system
• Prepare a compliance plan for closure of gaps ( if any)
• Execution of compliance plans
• Review of completion for compliance activity
• Review and certification of validation reports after execution of validation of facility /equipment / product / process
• Assuring quality of products by : Review of GxP document e.g. Master Batch Manufacturing & Packing Records, Specification and method of analysis. cGMP Training : To develop training modules and organize training in GMP
• Develop and execute the overall training program in coordination with all concerned departments
• Other: Preparation, review and approval of site master file
• Preparation, review and approval of high quality documents

Benefits

Additional Information

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 good quality of products to meet with customers' requirements, living Group's Values and Code of Ethics.

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