Sandip Pawar
Quality Assurance
Thane (West)
Summary
Results-oriented professional with 20+ years of experience in the pharmaceutical industry. Seeking career-enriching assignments. Expertise in regulatory requirements, quality assurance, quality management systems, product development, vendor qualification, contract manufacturing, audits, training and development, production operations, project management, process improvement, formulation development, and life cycle management of pharmaceutical products. Key role in successful submissions, approval, and commercialization of 200+ formulations for US, EU, Australia, ROW, and India markets. Strengths in managing strategic and operational performance while ensuring compliance. Hands-on experience with quality tools such as FMEA and 5 Why analysis. Proficient in reviewing various documents including dossiers, quality by design documents, FMEA, quality risk management reports, pre-formulation data, manufacturing guidelines, product development reports, technology transfer documentation, BMRs/BPRs, validation protocols (IQ/OQ/PQ), SOPs, and conducting statistical analysis. Recognized as an approved technically competent individual by FDA Maharashtra for sterile ointment manufacturing.
Overview
1
1
year of professional experience
Work History
Management staff - Quality Assurance Manufacturing unit.
Cipla
- Review of equipment, system, utilities, and instruments are Qualified before use and their qualified state is maintained
- Conduct and provide the initial and final review of the in-process and finished product batch records
- Check that only validated processes are used for the manufacturing and testing of products
- Ensuring manufacturing operations are compliant with cGMP and regulatory agencies
- Responsible for following environmental health and safety procedures
- Responsible for review of Master documents and executed documents like BMR, BPR, Validation protocol, hold time Study Protocols, etc
- Preparation of APQR
- Review of analytical testing reports, stability data, etc
- Facilitate proactive solutions by collecting and analyzing quality data, reporting all deviations in the manufacturing process, and ensuring CAPA on it as applicable
- Preparation of process chain for cleaning validation and identification of worst-case product
- Checking materials from approved vendors are used in the process and are qualified in a consistent manner.
Production In-charge (Capsule, Ointment, Injection Manufacturing Department)
BDH Industries Limited
- Monthly planning of batches as per export order and timely execution of batches of the capsule, ointment, and injection
- Area validation, Media fill, terminal sterilization
- Assure the reliability and consistency of production by checking processes as per process and final output
- Ensuring that the products produced are of consistent quality standards appropriate to their intended use and as required by the Marketing authorization or product specification
- Ensure all the deviations, incidences, and nonconformance are documented, investigated, and closed (wherever applicable) along with the corrective and preventive actions before the release of a batch
- Appraise customers’ requirements and make sure they are satisfied
- Ensure that the recognized cGMP requirements and quality standards are understood and maintained it across the department
- Ensuring that all activities are performed as per company SOPs, health, and safety policies
- Manage and ensure training of relevant change management programs throughout the department
- Maintaining and improving departmental performance to meet target requirements regarding production
- Ensure optimum utilization of resources available and comply with agreed timelines of internal and external customers
- Undertaking duties of another department within the company which are requested by the line manager
- Ensuring good relations and communications with all members of the team.
Sr. Manager –Quality Assurance
Rubicon Research
4 2023 - Current
- Overall responsible for SOP Management, approval, and effective implementation of the documentation Control system
- Responsible for approval of Master documents Batch Manufacturing Record (BMR) and Batch Packing Record (BPR), Validation Protocol, Validation report, etc
- Ensuring review of documents like Method validation, Technology transfer report, BMR, BPR, Validation protocol, Validation report, Photo-stability study, OOS, OOT, APQR, IQ, OQ, PQ, etc
- Ensure that the CMC documents are reviewed to identify issues, non-conformances, consistency, and appropriateness
- Review batches of pilot scale to exhibit and commercial batches for process parameters and ensure compliance with them
- Ensure review of documents like technology transfer documents of the product
- Attend the regulatory audits and ensure suitable compliance as required promptly
- Reviewing master and Executed CMC documents of the dossier
- Preparation of necessary documents to ensure compliance with the standards and requirements of Regulatory Authorities
- Ensure that the Product Quality is reviewed yearly (APQR) to identify issues, non-conformances, consistency of the existing process, and appropriateness of current specifications of starting materials and finished product to take up process and quality improvements as required
- New product launches, and extensions documentation
- Support business continuity renewals, CMC variations, post approval documentation
- Ensure regulatory compliance to applicable regulations, Track and maintain the product lifecycle on a regulatory database for assigned portfolio
- Ensure the designing and effective implementation of the Quality Management System and Good documentation practices
- Ensure the effective implementation of Quality Management Systems like change control, deviation, Quality Risk Management (QRM), incidents, market complaints, corrective action preventive action, out of Specification (OOS)
- Ensure appropriate investigations and root cause analysis w.r.t
- OOS, incidence report, deviations, and ensure appropriate CAPA is implemented to prevent recurrence of the same
- Ensure that the training management system is implemented as per the SOP
- Ensure that training is conducted as per the training schedule and training needs
- Ensure that training on updates / new regulatory guidance in the department.
Group Leader-F&D QA
Cipla
03.2024 - 05.2024
- Supervising the development of departmental SOPs (writing, revising, and approving)
- Performing inspections at vendors Deploying various methodologies to analyze processes, recommending modifications to minimize escalations, reduce rejection, realize operational efficiencies, control variability, and reduce cycle time
- Monitoring adherence to the quality management system and conducting a compliance check regarding quality framework documents to increase efficiency
- Ensuring implementation of audit recommendations for enhancing process and product quality
- Contributing to the implementation of various Software and IT solutions
- Imparting QMS training and designing and implementing SOPs for the same
- Ensuring review of documents like Quality by Design Document, FMEA, quality risk management, Pre-formulation Data, Method validation, Manufacturing Guidelines, Product Development Report, Technology transfer report, BMR, BPR, Validation protocol, in-use Study Protocol, Thermal cycling study, photo-stability study, Change Control, Filter validation, Admixture study, Bubble point, QMS Document, OOS, OOT, statistical analysis, Dossier, APQR, IQ, OQ, PQ, etc
- Review of executed documents of registration batches, trending, and statistical analysis for cpk and ppk
- Review of Third-Party Development (CRO) Documents
- Review of Change Control, CAPA (Trackwise)
- Support to Manufacturing Unit for Regulatory Audits
- Performing audits and preparation of audit reports as per timeline and circulating audit reports with suppliers to get CAPA for audit observations
- Review CAPA provided by suppliers
- Escalation of critical issues identified during audits to senior management.
Management staff- F&D Quality Assurance
Cipla
03.2024 - 03.2024
- Review of documents like Pre-formulation Data, Manufacturing Guidelines, Product Development Report, BMR, BPR, Validation protocol, in-use Study Protocol, Thermal cycling study, photo-stability study, Change Control, QMS Document, OOS, OOT, statistical analysis
- Ensure compliance with SOPs policies required by the company and Regulatory agencies
- Participate in quality and process improvement initiatives
- Review of Deviation, CAPA, and investigations
- Played a key role as part of Software Development required for formulation development
- Taking stringent quality measures including preparation of necessary documents to ensure compliance with standards and requirements of Regulatory Authorities to minimize the gaps in the documents
- Prepared Guidance-specific protocols e.g
- Chewable tablets, Breakability study of tablets, etc
- Ensuring on-time deficiency response to the Regulatory Agency
- Review of dossier data before submission
- Use of statistical analysis on data generated during development and regulatory batches for Capability analysis, Tolerance interval, etc.
Management staff -Regulatory Affairs
Cipla
11.2024 - 03.2024
- Preparation of CDT and Non-CDT dossiers for submissions
- To provide updated regulatory requirements to concerned stakeholders to maintain stringent requirements of various regulatory bodies
- Review and feedback for documents like BMR, BPR, Validation protocol, Change Control, PDR, analytical method validation, stability, etc
- Ensure compliance with documentation
- Coordinate with external stakeholders like customers, consultants, suppliers, etc
- Ensuring quality standards and submissions meet the timelines.
Sr. Manager –Formulation Development QA
Cipla
05.2024 - 03.2023
- Responsible for approval of Master documents Batch Manufacturing Record (BMR) and Batch Packing Record (BPR), Validation Protocol, Validation report, etc
- Responsible for reviewing and monitoring documents of QbD-based development for the US (ANDA, NDA), EU, Australia, South Africa, and the rest of the world
- Ensuring review of documents like Product Development Reports, Quality by Design, FMEA, Pre-formulation batches data, Method validation, Manufacturing Guidelines, Technology transfer report, BMR, BPR, Validation protocol, Validation report, In-use Study, Thermal cycling study, Photo-stability study, OOS, OOT, statistical analysis, Dossier, APQR, IQ, OQ, PQ, documents for the pre-IND meeting, etc
- Ensure that the Product development data and CMC documents are reviewed to identify issues, non-conformances, consistency, and appropriateness
- Responsible for review of the CMC documents for CMO projects (includes assessing the site regulatory/audit status and review of exhibit batch documents)
- Interaction with CMO Quality personnel for facilitating effective First-Time right documents of exhibit batches, and availability of Chemistry documents
- Review batches of scaling up from lab scale to pilot scale to exhibit and commercial batches for process parameters and ensure compliance with it
- Ensure review of tech-mar, stability, and ranges evaluated in development and scale-up batches
- Ensure review of documents like Manufacturing Guidelines, technology transfer protocol, control strategy CMA, CPP, and CQAs of the product
- Review of ranges evaluated during the registration of batches and their impact on Quality attributes
- Support to Manufacturing unit for the regulatory audits and ensure suitable compliance as required promptly
- Preparation of necessary documents to ensure compliance with the standards and requirements of Regulatory Authorities
- Ensuring on-time deficiency response from formulation to the Regulatory Agency, minimizing cycle time, to launch the product on time
- Checking the applicability of the deficiencies received on submitted products to the products in development to minimize the deficiencies on the product and review cycle time
- Reviewing documents for dossier and variations like CB0, CB30, APQR, post-approval changes, etc
- Ensure that the Product Quality is reviewed yearly (APQR) to identify issues, non-conformances, consistency of the existing process, and appropriateness of current specifications of starting materials and finished product to take up process and quality improvements as required
- Ensure the designing and effective implementation of the Quality Management System and Good documentation practices
- Ensure the effective implementation of Quality Management Systems like change control, deviation, Quality Risk Management (QRM), incidents, market complaints, corrective action preventive action, Out of Specification (OOS)
- Ensure appropriate investigations and root cause analysis wrt OOS, incidence report, deviations, and ensure appropriate CAPA is implemented to prevent recurrence of the same
- Responsible for effective implementation of self-inspection and subsequent corrective and preventive actions
- Conducting internal quality audits for checking QMS and process effectiveness
- Ensure that the training management system is implemented as per the SOP
- Ensure that training is conducted as per the training schedule and training needs
- Ensure that training on updates / new regulatory guidance in the department.
Education
M. Pharmacy -
Meruling Shikshan Sanstha’s College of Pharmacy, Shivaji University, Medha
B. Pharmacy - undefined
Vidyabharti College of Pharmacy, Amravati University, Amravati
D. Pharmacy - undefined
Govt. College of Pharmacy, Karad
12th - undefined
Sadguru Gadge Maharaj College, Karad
Skills
Regulatory requirements
Dossier review
Project Management
Process Enhancement & Cost Control
Training and Development
Six Sigma
Production Operations
Team Management
Audit and Inspection
Mechanistic modelling and simulation
Strategic Planning
Quality by design
GMP
Registration batches review
Technology transfer
Total Quality Management
Product development report
Contract manufacturing
Handling of Complaints
Handling of deficiencies
QMS
Friendly, Positive Attitude
Teamwork and Collaboration
Computer Skills
Calm Under Pressure
Personal Information
Date of Birth: 11/01/79
Notableaccomplishments
- Exemplary performance and implementation of management measures. Assured observations/ nonconformances are investigated and completed reports.
- CMC submission documents reviewed for 200+ formulations for the USA (ANDA, NDA), EU, Australia, South Africa, ROW market, successful approval, and commercialization of formulations such as Tablets, Creams, Injections, Liquid orals, etc.
- Answered 1000+ deficiencies of formulations, process development, and analytical.
- Expertise in reviewing Product development reports, Quality by Design (QbD), and submission documents.
- Expertise in reviewing documents for dossier and variations like CB0, CB30, APQR, etc.
- Audit experience in Drug product manufacturing, formulation development, and excipient manufacturing.
- Approval of Competent Technical Staff from the FDA in manufacturing of Sterile Ointment and cream
- Played a key role as part of Software Development required for formulation development.
Languages
English, Hindi, Marathi
Timeline
Management staff -Regulatory Affairs
Cipla
11.2024 - 03.2024
Sr. Manager –Formulation Development QA
Cipla
05.2024 - 03.2023
Group Leader-F&D QA
Cipla
03.2024 - 05.2024
Management staff- F&D Quality Assurance
Cipla
03.2024 - 03.2024
Management staff - Quality Assurance Manufacturing unit.
Cipla
Production In-charge (Capsule, Ointment, Injection Manufacturing Department)
BDH Industries Limited
Sr. Manager –Quality Assurance
Rubicon Research
4 2023 - Current
M. Pharmacy -
Meruling Shikshan Sanstha’s College of Pharmacy, Shivaji University, Medha
B. Pharmacy - undefined
Vidyabharti College of Pharmacy, Amravati University, Amravati
D. Pharmacy - undefined
Govt. College of Pharmacy, Karad
12th - undefined
Sadguru Gadge Maharaj College, Karad