Dipak B. Ghongade

• Oversee Quality Assurance (QA) activities on the shop floor and within the Quality Management System (QMS).
• Lead QA initiatives, ensuring compliance with GMP and regulatory standards.
• Implement ALCOA+ principles to uphold data integrity.
• Review and approve change controls, SOPs, equipment qualifications, new product introductions, and audit compliance.
• Act as a Subject Matter Expert (SME) during audits, ensuring timely compliance.
• Review quality risk management document
• Develop and negotiate Quality Agreements with third-party organizations.
• Review and approve stability studies, process validation, and analytical validation protocols.
• Facilitate external audits and drive corrective action plans.
• Conduct GMP training, self-inspections, and shop floor compliance assessments.
• Ensure timely closure and effectiveness monitoring of QMS events.
• Oversee change control, CAPA, APQR, material specifications, and equipment qualification documents.
• Track and manage change control and CAPA action plans.
• Monitor the effectiveness of corrective actions and preventive action.
• Evaluate and implement global CAPA strategies at the site.
• Identify and report operational gaps for improvement.
• Conduct GEMBA walks and self-inspections to ensure audit readiness.
• Release finished goods
• Review critical documentation, including shop floor and laboratory investigations, master batch records, validation protocols, and QMS reports.
• Provide training on data integrity, documentation practices, GMP, sampling procedures, and regulatory inspections.
• Monitor QMS performance metrics for timely event closure.
• Allocate and manage team resources efficiently.
• Uphold company values of respect, care, collaboration, entrepreneurial spirit, customer focus, and teamwork.
• Adhere to the Code of Conduct, Business Ethics, and all regulatory, compliance, and safety requirements.
• Led cross-functional teams to develop and implement strategic initiatives, enhancing operational efficiency and achieving key business objectives.
• Facilitated training programs for staff, fostering professional development and enhancing team performance across departments.
• Developed and implemented performance metrics to assess project outcomes, driving accountability and continuous improvement initiatives.
• Spearheaded cross-functional initiatives that streamlined operations, improving overall efficiency and significantly enhancing team collaboration.
• Facility approval - USFDA, WHO, FDA, ANVISA
• AUDIT FACED - USFDA, WHO, THIRD PARTY AUDIT
• FUNCTIONAL AREA – TABLETS AND CAPSULES

1. Oversaw IPQA, process validation, & cleaning validation activities.
2. Supervise manufacturing assurance activity and quality compliance of manufacturing facility.
2. Ensure GMP documentation compliance and quality system implementation.
3. Preparation, review and implementation of protocol study and SOP’s.
4. Ensure in process sampling activities and its submission to the respective department.
5. Responsible to checks the online documentation and investigate OOS, incident, deviation, market complaints and ensure implementation of CAPA and change control etc. on shop floor.
6. Responsible for initiation of change control/ incident/ deviation/ CAPA
7. Responsible for IPQA section requirement and planning of shift activities.
8. Ensure to follow Good manufacturing practices at shop floor.
9. Responsible for reducing the market complaint and product recall through effective in-process control and cGMP.
10. Timely and effective communication of quality issues to the appropriate levels of management.
11.Management of process validation batches and hold time study batches.
12. Responsible to ensure team members are trained by providing training on relevant SOP’s
13. Check and perform SAP related activity and compliance.
14. Responsible to attend the training sessions as per schedule Training needs identification.
15. Communication to seniors and subordinate related to the manufacturing activities on daily basis.
16. Responsible for review and verification of executed process / exhibit batch manufacturing record.
17. Responsible for submission of BPR to QP.
18. Review of quarantine dispatch request for Europe QP approval.
19. Ensure compilation of Batch production data in APQR trend.
20. Responsible for review and support to production for technology transfer of new products execution in the facility.
21. Maintain Environment, Health and Safety system as per ISO 14001:2015 and ISO 45001:2018.

Facility approval - USFDA, MHRA, TGA,ANVISA
AUDIT FACED – USFDA AND MHRA
FUNCTIONAL AREA – TABLETS, CAPSULES

• Managed IPQA, process validation, and cleaning validation activities.
• Supervised manufacturing assurance and quality compliance in the facility.
• Ensured GMP documentation compliance and quality system implementation.
• Prepared, reviewed, and implemented study protocols and SOPs.
• Oversaw in-process sampling and ensured timely submission to relevant departments.
• Conducted online documentation checks and investigated OOS, deviations, market complaints, and CAPA implementation.
• Initiated and managed change control, deviations, and CAPA processes.
• Planned and managed IPQA section requirements and shift activities.
• Ensured adherence to GMP on the shop floor.
• Minimized market complaints and product recalls through effective in-process controls and cGMP compliance.
• Communicated quality issues promptly to management.
• Executed and managed process validation and time study batches.
• Provided training to team members on relevant SOPs.
• Performed SAP-related activities and ensured compliance.
• Attended training sessions as per schedule and identified training needs.
• Maintained daily communication with seniors and subordinates regarding manufacturing activities.
• Reviewed and verified executed process/exhibit batch manufacturing records.
• Ensured timely submission of BPR to Qualified person
• Reviewed quarantine dispatch requests for European QP approval.
• Compiled batch production data for APQR trends.
• Supported production and technology transfer for new product execution.
• Maintained Environment, Health, and Safety (EHS) systems as per ISO 14001:2015 and ISO 45001:2018 standards.
• Facility approval - MHRA, PMDA
• AUDIT FACED – MHRA, PMDA
• FUNCTIONAL AREA – Tablets and capsules

• Execute process and cleaning validation activities.
• Conduct sampling at various manufacturing stages, including blend, core, and coating.
• Perform blend and semi-finished goods (SFG) release in SAP.
• Track process validation batches.
• Ensure manufacturing compliance during daily IPQA activities.
• Review executed batch production records (BPR) for manufacturing and packaging.
• Conduct area and equipment line clearance.
• Facility approval - USFDA, MHRA, TGA, ANVISA
• AUDIT FACED – MHRA and USFDA
• FUNCTIONAL AREA – Tablets and capsules

• Prepare Batch Manufacturing Records (BMR).
• Participate in IPQA activities during manufacturing.
• Report non-compliance incidents during manufacturing.
• Prepare and clear the Annual Product Review (APR).
• Prepare and issue Material Safety Data Sheets (MSDS).
• Maintain documentation for deviations, change control, and market complaints.
• Facility approval - WHO
• AUDIT FACED – CUSTOMER AUDIT
• FUNCTIONAL AREA – Tablets and capsules

• Lecturer (Pharmaceutics) – Siddhant College of Pharmacy, Pune (March 2008 – May 2010) | 2 Years 2 Months
• Subject taught such as Pharmaceutics, Pharmaceutical microbiology and pharmaceutical unit operation
• Approved lecturer for subject pharmaceutical microbiology

• Research Associate (Formulation & Development) – Alkem Labs, Navi Mumbai (April 2007 – November 2007) | 8 Months
• Develop Carbamazepine ER tablets