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