Dhananjay Saindane
Pharmaceutical Quality Assurance
Mumbai
Summary
- Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
- Reliable employee seeking Manager Position. Offering excellent communication and good judgment.
- Project 1: In Lupin - Involved in SAP system improvement project to avoid manual practices and redundant work in vendor management system of Lupin ltd.
- Project 2: Developed API technology transfer system, supplier management with help of R&D and purchase in Indoco remedies Ltd.
- Project 3: Prepared URS of equipment, water system, HVAC system, facility as regulatory requirements during facility renovation in Indoco remedies Ltd.
- Dedicated pharmaceutical quality assurance professional with history of meeting company goals utilizing consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand.
Overview
17
17
years of professional experience
6
6
years of post-secondary education
1
1
Certification
Work History
Sr. Executive - Corporate Quality Assurance
Lupin Ltd.
Navi Mumbai
02.2016 - Current
- Performing outsourced materials vendor audits for API, KSM, Excipient, Gas, Printed and Primary packaging material, Secondary packaging material as per applicable guidelines.
- Prepare audit reports as per regulatory expectation.
- Reviewing vendor audit compliance accordingly decided approval and rejection of vendors.
- Reviewing of vendor/ supplier quality risk management, vendor qualification documents, assessments.
- Handling of vendor/ supplier change notification, vendor regulatory action evaluation and recall intimations on qualified vendor.
- Handling impact evaluation of vendor complaints.
- Administrator of Caliber QAMS module which comprises change control, Deviation, Customer compliant, OOS etc. Give the solutions on problem in day to day activity and ensured the CSV activities.
- Worked flexible hours across night, weekend and holiday shifts.
- Maintained excellent attendance record, consistently arriving to work on time.
- Created plans and communicated deadlines to complete projects on time.
- Resolved conflicts and negotiated mutually beneficial agreements between parties.
- Actively listened to vendors, handled concerns quickly and escalated major issues to supervisor.
- Carried out day-to-day duties accurately and efficiently.
- Worked within applicable standards, policies and regulatory guidelines to promote safe working environment.
Executive- Quality Assurance
Indoco Remedies Ltd.
Navi Mumbai
07.2008 - 02.2016
- Small scale manufacturing multiproduct Kilolab plant is build in Indoco to facilitate immediate DMF filing of costly drugs. The products manufactured in Kilolab has been approved by USFDA (2012, 2015), TGA (2012). The plant was renovated in year 2009 to comply USFDA regulation standards.
- As part of the team faced regulatory audits of USFDA, MHRA, Cofepris, KFDA of Indoco Remedies Ltd. (More than 6) which were successful.
- As part of the team and alone handled customer audits of API. (More than 20)
- During renovation of Kilolab plant, Quality Management System procedures, Unit operations procedures, General procedures of QA, QC, Production, Engineering, and Warehouse were designed, reviewed and effectively implemented.
- Prepared and reviewed apex documents like site master file, quality manual, department manual, validation master plan documents.
- Prepared and reviewed of qualification protocol and reports of equipment, instruments, facility, AHU system, water system, utilities.
- Monitored and ensured the compliance of Technology transfer of API and intermediates from R&D to Kilolab.
- Prepared and reviewed process validation, cleaning validation protocol and reports activities were monitored and reviewed relevant documents.
- Quality management systems like Change control, deviation, OOS, incident, self-inspection, training, return goods, product complaints, corrective & preventive action were ensured and updated.
- Review completed batch production record, analytical raw data records to ensured Quality of batch , data governance ensured prior to release of batch. Verified re-packaging and labeling activity during batch distribution and maintained batch distribution record.
- Equipment line clearance approval, daily production, quality control inspections to ensure GMP, GLP compliance.
- Ensuring that vendor should comply with the requirements of EU GMP/ MHRA and USFDA. Vendor qualification document (critical raw material and packaging material) were reviewed. Preparation of approved vendor list, preparation of vendor audit schedule. Performing vendor audit for KSM, reviews of audit compliance report.
- Customer audit compliance report prepared and implement necessary corrective actions to audit findings.
- Impact assessment of non compliance evaluated, investigate the root cause of non compliances, implement the CAPA and evaluate CAPA effectiveness.
- Prepared annual product quality review.
- Prepared and monitored self-inspection schedule and conduct the internal audits of QC, Production, Engineering and warehouse.
- Support to regulatory affairs for DMF filing.
- Conduct GMP, SOP trainings to all concerned.
- Conducted regular meetings with team to discuss issues, concerns and updates.
- Established and implemented departmental policies, goals and objectives.
- Prepared and drafted new policies to benefit company in meeting objectives.
Management Officer
Cipla Limited
Pune, Kurkumbh
01.2006 - 06.2008
- BMR, GMP controlled documents as per request issued to departments.
- Completed Batch Manufacturing Record reviewed for batch release.
- Rinse samples and swab samples of cleaning validation collected from production equipment. Process Validation samples from dryers, blenders withdrawn from process equipments.
- QMS systems, e.g. Change Control, Deviation, Market Complaint, etc. are implemented and ensured.
- Conducted the SOP training to new employee.
- Prepared and reviewed of process validation protocol and report, cleaning validation protocol and report, annual product quality review.
- Take daily production round on floor to ensure GMP, GDP.
- Part of the team of regulatory audits of USFDA, MHRA, WHO at Cipla Ltd. D-7 kurkumbh.
- To ensure that appropriate in-process controls/ online checks are being performed, participate in the investigation of the market complaints.
Education
Master of Science - Inorganic Chemistry
Pratap College
Amalner, Jalgaon 06.2001 - 06.2004
Bachelor of Science - Chemistry
Jaihind Educational Trust
Dhule 06.1999 - 06.2001
Diploma in Medical Laboratory Technology -
Karmavir Bhaurao Patil Paramedical Institute
Dhule 06.2004 - 06.2005
Skills
Knowledge of regulatory act and guidelines for Pharmaceuticals eg 21 CFR part 210, 211, ICH Quality guidelines, EU volume 4, ISO 9001:2015 QMS, ISO 15378- Primary Packaging Material for medicinal product, D&C act, Schedule M, APIC, PICs/GMP
Audit and Compliance: Vendor and Regulatory Audits
Computer Proficiency: Basic Computer Education, Excellent in Windows, MS Office suite: Expertise in the usage of Word, Excel, and PowerPoint presentations
Software exposure: SAP, QAMS (caliber)
Quality assurance procedures
Quality Assurance Investigation
Certification
Certified as GMP auditor by corporate event management in Lupin Ltd.
Certified as GMP auditor by corporate event management in Lupin Ltd.
Comprehensive Programme organized by external faculty to Qualify Auditor for conducting vendor audits.
Timeline
Certified as GMP auditor by corporate event management in Lupin Ltd.
11-2016
Sr. Executive - Corporate Quality Assurance
Lupin Ltd.
02.2016 - Current
Executive- Quality Assurance
Indoco Remedies Ltd.
07.2008 - 02.2016
Management Officer
Cipla Limited
01.2006 - 06.2008
Diploma in Medical Laboratory Technology -
Karmavir Bhaurao Patil Paramedical Institute
06.2004 - 06.2005
Master of Science - Inorganic Chemistry
Pratap College
06.2001 - 06.2004
Bachelor of Science - Chemistry
Jaihind Educational Trust
06.1999 - 06.2001