Dr. Jaideep Jadhav Email & Phone Number

Mumbai, Mh, In

Mumbai, Maharashtra, India

Mumbai Area, India

The role is to support and monitor the overall activities in Quality Assurance, Analytical, Formulation and Engineering departments adhering to Quality and Compliance, during the product development life cycle processes and also to ensure related practices adhere to Micro Labs R&D Quality Manual and regulatory requirements.In order to monitor continuous improvement and maintain procedures, to ensure compliance during these product development R&D activities with regulations, follow… Show more The role is to support and monitor the overall activities in Quality Assurance, Analytical, Formulation and Engineering departments adhering to Quality and Compliance, during the product development life cycle processes and also to ensure related practices adhere to Micro Labs R&D Quality Manual and regulatory requirements.In order to monitor continuous improvement and maintain procedures, to ensure compliance during these product development R&D activities with regulations, follow activities are performed;-Support R&D team to adhere in Quality & Compliance, during the process of developing new products as required by the intended market.-Support & ensure that the Regulatory Authority, Local Authority & Micro Labs Quality systems are met by the R&D team.-Lead and support Quality / Compliance initiatives to improve / harmonize Micro Labs Quality Systems.-Ensure compliance with all Company policies and procedures, including safety rules and regulations-Monitor for implementation, training and periodic review of R&D SOPs and QAPs.-Review/ approve QA related documents, including, batch documentation, equipment qualification, calibration related documents and CDP protocol documentation.-Monitor QA systems such as Change Control, Deviation, Lab incident, CAPAs for R&D and support for timely closure of this QMS documents.-Performs cGMP audits of R&D as on when required which includes the audits of ADL, FRND, Admin, Engineering and IT facilities, as well as 3rd Party vendors.-Provide support to management during third-party (Regulatory Authorities) audits, evaluate and follow up on the appropriateness and completeness of corrective action until closure.-Prepare technical reports, if required and provide status reports on compliance initiatives to management, as and when required. Show less

Hingwadi, Pune

Proactively participated for monitoring Pharmaceutical Compliance within the company and working mainly as Analytical/ Quality Management System Expert.Was Certified as a Lead Auditor and audited various Manufacturing units, CROs and Contract Testing Labs. Was heading two groups in which one group was handling all Emcure Vendor Audits (Globally) and second group who was assessing the Non-US market commercial batch documents (BMRs, BPR, Laboratory documents which includes raw data) to… Show more Proactively participated for monitoring Pharmaceutical Compliance within the company and working mainly as Analytical/ Quality Management System Expert.Was Certified as a Lead Auditor and audited various Manufacturing units, CROs and Contract Testing Labs. Was heading two groups in which one group was handling all Emcure Vendor Audits (Globally) and second group who was assessing the Non-US market commercial batch documents (BMRs, BPR, Laboratory documents which includes raw data) to check for compliance before releasing the batches by QA.Being in Compliance Team, also proactively participated in complying with Pharmaceutical Compliance within the company like;- Examined the effectiveness of established policies, standards, and procedures at various plants (Solid Orals, Sterile manufacturing, high potent drug product manufacturing (Oncology) and API.- Randomly verified or assessed or audited electronic data generated through laboratory instruments including chromatography.- Reviewed both manufacturing and laboratory analytical documentation on periodic basis for accuracy and compliance to establish procedures.- Provided support during regulatory authority inspection.- Reviewed investigations and corrective actions to ensure complete, thorough, accurate and timely evaluation of non-conformance and prevention of recurrence.- Supported the Head Compliance Cell in preparing reports of the Compliance Cell to present to the CEO.- In absence of Head Compliance Cell, interacted with Company CEO / Senior Management to establish policies and for other compliance-related matters.- Maintained a data base of all the published Warning Letters and used them as a training tool to inform and educate employees of the “Do’s and Don’ts”.- Organized effective training and education for the employees.- Performed regular internal monitoring and audits.- Established effective communication with all departments. Show less

Hingwadi, Pune

Managed a QC staff of around 56 employees, which included Group Leaders, Supervisors, Executives, Officers and Chemists.Looked after all QC related activities of Sterile Division (Injectable Unit)

I.T.B.T. Ppark,, Phase Ii, Midc, Hinjwadi, Pune

- Actively involved in Remediation Action Plan (RAP) after US FDA audit by playing a key role in solving the issues related to Data Integrity.- Took over the charge of RAP Project Coordinator from a Consultant Project Coordinator duringtransition.- As a Project Coordinator served as a dedicated, on-site resource, responsible for managing the project, organizing all team activities and timelines, monitoring and reporting progress to the Steering- Committee which consisted of… Show more - Actively involved in Remediation Action Plan (RAP) after US FDA audit by playing a key role in solving the issues related to Data Integrity.- Took over the charge of RAP Project Coordinator from a Consultant Project Coordinator duringtransition.- As a Project Coordinator served as a dedicated, on-site resource, responsible for managing the project, organizing all team activities and timelines, monitoring and reporting progress to the Steering- Committee which consisted of senior Emcure Corporate Management and a Consultant Head to provide strategic direction for the project, allocate resources when necessary and escalate any potential concerns to the CEO for executive decision.- As a Project Coordinator tracked all FDA commitments, ensuring all are identified as ‘met’ until theyhave been verified as adequate by an independent reviewer- Organizing weekly Working Teams meeting with representatives from each of the disciplines/areas of evaluation to check the progress updates.- Maintained data base of all the 483 or inspectional observations / citations and pertaining CAPAs implemented across Emcure. Conducted routine verification of these CAPAs. Show less

Mulund W, Mumbai

Indeus Life Sciences is a wholly owned subsidiary of the Nordic Group, Netherlands, and affiliate ofDisphar International; it acts as Disphar’s in-house centre for pharmaceutical formulation – andanalytical development- As a core team member, was responsible for assisting in designing and setting-up Analytical Lab(from inception), and provided support to the QA team during the EU –GMP inspection in 2012- Provided support to the formulation development department for analysis… Show more Indeus Life Sciences is a wholly owned subsidiary of the Nordic Group, Netherlands, and affiliate ofDisphar International; it acts as Disphar’s in-house centre for pharmaceutical formulation – andanalytical development- As a core team member, was responsible for assisting in designing and setting-up Analytical Lab(from inception), and provided support to the QA team during the EU –GMP inspection in 2012- Provided support to the formulation development department for analysis of various formulations- Provided information on project costing, planning and developing strategies for analytical projects.- Was spearheading the total accountability of all Analytical Department activities like;- Imparted training to team regarding functioning of the analytical laboratory.- Pre-costing of all Analytical activities required to run a project.- Follow-up with API suppliers for standards, test procedures and other open parts with the help ofparent company Logistic department.- Audited the API manufacturing plants when required.- Supported the development teams and Analytical team during method development and methodvalidation.- Helped in drafting of Validation Protocols and Reports.- Drafted monthly reports based on the activities carried out in Analytical lab.- Monitored progress of the projects.- Discussed strategic issues, which require discussion/decisions/ proposals to management both atIndeus and with parent companies (Disphar, Netherland) Project Managers through frequent Videoconferences and Telecons;- Was responsible for complete release of finish product manufactured in R&D and Commercialmanufacturing area.- Was authorized as QP in signing up all analytical related documents.- Prepared Analytical tech-transfer documents required during project transfer at CMOs in Europe.- Helped QA in drafting the reports and queries raised by regulatory departments on technicalanalytical documents. Show less

Mumbai Area, India

Heading the total accountability of all Analytical Development activities, supporting- Formulation Group- Synthetic API group- Herbal Formulation group- Managing a total strength of 18 chemists.- Analytical support to other locations, providing support for market complaints and to theregulatory department for queries received from authorities

Andheri (E), Mumbai

-Worked in Caraco Pharmaceuticals Ltd, Detroit, USA, during SUN Pharmaceuticals tenure anddid Technology Transfer of 2 Products.-Functioned as a Group Leader, worked on ANDA and Local projects.-Got exposure in setting a Lab in New R& D centre at Andheri, Mumbai.-Recipient of award for outstanding performance in the years 2000 & 2004

Surat Area, India

-Worked in synthetic R&D lab and carried out reactions like Condensation, Chlorination, Sulphonation,Nitration, Reduction, Alkylation, Diazotisation, Hydrolysis, Acetylation etc.-Initiated reactions by usage of Phenols and Cresols material to prepared 15 to 20 different types of aminodiphenyl ethers.

Dombivali, Kalyan

Worked in the accredited laboratory with OECD/USA-EPA-GLP, NABL and ISO 9002 Certifications.- Estimated Tetra Chloro Dioxins and Benzofurans (TCDD and TCBF) and Polychlorinated Biphenyl (PCB)in some finish products up to PPT level on GC-MS.- Supported International Marketing Department by preparing documentation as per National andInternational requirements.- Recipient of “Performance Award” in 1998.

Doctor Of Philosophy - Phd, Chemistry

Topic - Coal Utilization Processes - Synthetic & Performance Evaluation of Carbon Molecular Sieves and Engineered Composite Media.

Master Of Science, Organic Chemistry

Pg Diploma In Qa/Qm, Quality Assurance And Quality Management Systems

Correspondence course on Quality Assurance and Quality Management Systems

Pg Diploma In Regulatory Affairs- Formulation, Regulatory Affairs- Formulation

Correspondence course in Regulatory Affairs- Formulation