Gopal Joshi Email & Phone Number

Ahmedabad, Gj, In

Paonta Sahib, Himachal Pradesh, India

Responsible for handling of Quality Assurance activities of Tirupati Group's four business verticals, i.e. Pharmaceuticals, Nutraceuticals, Ayurveda, and Sports Nutrition. Key roles and responsibilities:1. Improvement of productivity in manufacturing and quality.2. Establishment of strong internal audit and quality surveillance systems across the Group.3. Establishment of quality assurance system in product development process.4. Establishment of robust processes, knowledge, and tech transfer.5. Facilitating strong investigational capability in quality unit.6. Establishing robust product/process risk management and control.7. Assurance of ESG/SEDEX, statutory, GMP, and regulatory compliance.8. Facilitating automation in manufacturing process to minimize rejection, market complaints, recalls, and deviations.9. Harmonization of formulation, process, and specification.10. Implementation of computer system validation for SAP, LIMS, QMS, and DMS.11. Facilitating cost optimization projects - Line Balancing, Right-in-first-time, and Zero OLR.12. Technical query resolution of national and international customers.

Ahmedabad, Gujarat, India

Take advantage of my experience of 200+ audits (India and International). Contact me for GMP auditory services for your Pharma organization today!Email ID: gopal101390@gmail.comPhone No.: 9099993710You can also start a conversation with me in the Direct Message option of LinkedIn.

Gujarat, India

Highlights:Successfully faced regulatory agencies like PICS, Uganda, Kenya, Malaysia, and other countries and customers like Unimed UK, Dr. Reddy's Lab, Sun Pharma, etc.Key Responsibilities:1. Monitoring the Quality Metrics of the plants on a monthly basis, and sharing analytics data with management on a quarterly basis. (Lot acceptance rate, Invalidated OOS rate, repetitive deviation rate, Product complaint rate, training effectiveness rate, market complaint trend, CAPA effectiveness rate).2. Handling of market complaints, product recalls, and returned goods.3. Internal audit of plant and CAPA implementation to avoid its recurrence.4. Investigation of market complaint, identify the root cause and implementation of CAPA and tracking for its effectiveness.5. Investigation of deviation/incidences and CAPA effectiveness evaluation.6. Stability monitoring of products and OOS investigation, impact assessment and risk assessment for initiating suitable action like recall or field alert.7. Review of the various documents like STP, SOPS, BMR, MFC, Stability Protocols, Validation Protocols, Calibration Formats.8. Analytical method validation activity and its periodic verification.9. LIMS validation and ALCOA compliance in Lab to avoid any DI issue through audit trial.10. Training staff on applicability of risk management system during product technology transfer activity.11. Training of staff, induction training, cGMP training, on the job training, external training, quality culture training.12. Execution of process validation as per master validation plan, cleaning validation through matrix approach, HVAC periodic qualification, and Utility Qualification/verification.15. Product Quality review (PQR ) activity as per current regulatory expectations.

Ahmedabad Area, India

Highlights:1. Successfully led the due diligence team to facilitate Glochem Pharma Acquisition in India.2. Successfully led the due diligence team to faciliate Bio Pharma plant/company acquisition in the USA.Key Responsibilities:Data Reliability Cell - All Locations1. Responsible for Internal Audit and Compliance of Analytical Development Laboratory as well as Quality Control Laboratory, CMO, LL sites Audits for cGMP Compliance.2. Facilitating Data Integrity Audits for Quality Control Laboratories of all Torrent locations.3. Identification of risk associated with data reliability, propose suitable corrective and preventive action and monitor its implementation and effectiveness.4. Facilitating review of the Audit trail of all the Analytical Instruments i.e. HPLC and GC software.5. Facilitating the Qualification Audit of new CROs/CMOs and final clearance for their suitability.

Ahmedabad, Gujarat, India

Key Responsibilities:1. To ensure that PPC department is maintaining item-wise material inventory for minimum 60 days to 90 days as part of 3/1 plan.2. To ensure that 1 month firm manufacturing schedule and 1 month packaging schedule preparation is align to QC testing and products are timely released in SAP as per schedule.3. Separate planning for Exhibit batch manufacturing and effective technology transfer from R&D to plant production.4. To ensure the Preventive maintenance schedule for utility services is strictly adhered to and no deviation is taken.5. To ensure the availability of man power to complete the production target.6. To ensure that trained man power is available for machine operations.7. To ensure that deviation (if taken) at shop floor is closed timely and properly and CAPA implemented.8. To facilitate manufacturing investigation in reponse to Market complaint and OOS.9. To coordinate with marketing and SCM for timely transfer of goods from plant warehouse to central warehouse further to customer.10. To ensure timely release of raw material and Finished product to avoid manufacturing and delivery delay.11. To facilitate staff on GMP expectations of regulatory on quality culture.12. Willful compliance without exceptions even in absence of supervision.13. Complete transparency - No reporting errorts or discrepancies. 14. Meaningful investigation - To identify root causes.15. Refusal to do wrong even if directed by seniors.16. Immediate reporting of wrong doing.17. Data-based decision making rather than based on hierarchy.18. Culture of continuous learning and its application during everyday work.

Gujarat, India

Highlights:Successfully faced Latvia, Ukraine, Malaysia, Uganda, and Kenya audits.Key Responsibilities Handled:Plant QA1. Approval and execution of the validation master plan.2. Approval of various protocols like Qualification of Equipment, Cleaning Validation, Process Validation, Analytical Method Validation, Stability Testing Protocol, etc.3. Review and approval of batch manufacturing and packing control records.4. Training of personnel - On the job training, GMP training, Quality Culture training, process validation, cleaning validation, risk management, equipment qualification, HVAC qualification, and EM monitoring. Sterility assurance system - OOS/OOT/CAPA and PQR system.5. Investigation of deviation and approval of proposed corrective action.6. Self-inspection and Quality Audit of the facility.7. Investigation of market-compliant and appropriate measures to prevent a recurrence.8. Review and approval of the change of control procedure.9. Investigation of batch failure and its corrective action.10. Review of the various documents like STP, SOPS, BMR, MFC, Stability Protocols, Validation Protocols, Calibration Formats, etc. 11. WHO, Customer Audit Management, and Audit Response.12. Responsible for final certification of the Analytical Method validation protocol and report and ensuring the compliance to the SOP for Method validations.13. Internal Audit and Compliance.14. Successfully taken 3 batches for US dossier filing and compiled the process validation report.

Hyderabad, Telangana, India

Highlights:1. Successfully faced MCC, TGA, WHO, Uganda, Kenya audits, (ROW market - PICS compliance).2. Designing of Phase Gate as a part of the 'RACHANA' project.Key Responsibilities:Plant QA1. Timely review and approval of QMS documents like CCF/Deviation, market complaint investigation report, OOS documents.2. Identification of gaps in the existing quality management system (QMS) in formulation & further up-gradation of the QMS.3. Responsible for the quality assessment of the existing and new products for the related quality issues.4. Successfully transferred technology using technology transfer documents from R&D to plant for the execution of 3 Exhibit batches for ANVISA and EU market dossier filing.5. Development Data review for adequacy and accuracy as part of the Technology Transfer.6. The closing of the technology transfer process after completion of the process validation report.7. Designing of Phase Gate as a part of the 'RACHANA' project.8. Successfully taken exhibit batches for dossier filing and compiled the process validation report.

Bengaluru, Karnataka, India

Highlights:1. Awarded crystal bronze award from WTO for process and product development activity of reduction of capsule size of Fefol from size 1 capsule to size 2 capsule.2. Yield improvement of Bactroban ointment from 93% to 97.5%.3. Technical support to provide documental evidence from Ayurvedic textbooks for Iodex case in Court.Key Responsibilities Handled:Plant Manufacturing1. Implementation of BPCS ERP System in-store and manufacturing.2. Implementation of cleaning validation concept in manufacturing.3. Development of a new layout for the suspension area.4. Improvement in the water management system.5. Qualification of Air Handling Unit in manufacturing critical area to meet class D.6. Handled manufacturing operation of Ointments like Iodex, Bactroban, liquids like Crocin syrup, Zental suspension, Spensule capsules like Fefol, Fefol Z, and Fesovit capsules.7. Handled Capsule filling and sorting area independently.

Mysore, Karnataka, India

Tamil Nadu, India

M.Pharm

B.Pharm