zentiva
Website:
zentiva.com
Job details:
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.
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.
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 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.
Ensure Adherence To Company Quality Standards, Local And Global Regulations. Support Batch Release By Following Submission And Approval To Ensure The Product Regulatory Compliance On His Sites(s). To Ensures That The CMC Dossier Is In Line With Manufacturing And Control Procedures On Site(s) And With Dossiers Approved By Health Authorities. Carry Out Quality Compliance –GxP Review So As To
Understand the requirements for implementation
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
Preparation and Review of the regulatory dossiers along with response to authorities. Coordination with Internal and External stakeholders for maintenance of quality and regulatory compliance of products manufactured at Site Ankleshwar. Prepare for and attend External / Third Party/ Regulatory Quality Audits Performing as a “Qualified Internal Auditor” during internal Quality Audit abiding the internal quality audit schedule. Management of self-inspection system at site. Coordination with regulatory authorities for maintenance of site regulatory documentation Change Control: Initiate, review, evaluate and approve the Change Control and associated activities with regulatory impact along with change implementation at site CMC Documentation management : To write and review CMC regulatory documents/dossiers to be dispatched to Global Regulatory Affairs function for submission To maintain the regulatory dossiers at site To coordinate CMC writing performed by another entity (internal or external) To optimize the content of CMC dossiers to facilitate the management of future changes To prepares with contribution of site experts Answers to questions from Health Authorities To Support Marketing Authorizations worldwide (territory extensions, renewals, site registrations and transfers…) by writing the corresponding CMC documents/dossiers and collecting GMP related documents To prepare and authorize GxP / Quality & Regulatory Declarations / Statements for submission to Regulatory Authorities and Business Partners To provide support to Global Regulatory Affairs team for Global business projects, New Registrations and life cycle management of approved products
Validations & Qualifications:
Review of protocols for qualification and validation of facility/ equipment / product / process
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 as per ICH / regulatory requirements for submission to Health Authorities / Global Regulatory Affairs / Business Partners
Coordinating with various stakeholders for establishing quality technical agreements
Supplier audit, qualification and approval
Develop, implement, and maintain a robust supplier quality assurance system aligned with cGMP and regulatory requirements (e.g., USFDA, EMA, WHO).
Lead supplier qualification, requalification, and performance monitoring programs.
Conduct risk-based assessments and ensure supplier categorization based on product and service criticality.
Plan, conduct, and follow up on supplier audits (on-site and remote) for API, excipient, packaging, and service providers.
Evaluate audit findings, identify gaps, and oversee closure of CAPAs with suppliers.
Maintain audit schedules, records, and ensure timely reporting.
Maintenance of Approved Supplier List / GMP documents / Supplier files
To Act as a regulatory interface with Global Regulatory Affairs or with Affiliate Regulatory Affairs for site
To provide results of regulatory indicators applicable to site
To Implement appropriate company tools to manage identified activities
Contributes to site GMP inspections and audit
Review and sign-off documents like SOPs or technical reports
To perform the responsibilities as assigned by line Manager
Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations
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