Rajesh Dolas Email & Phone Number

Mumbai, Mh, In

Navi Mumbai, Maharashtra, India

Navi Mumbai, Maharashtra, India

Developing and driving continuous improvement initiatives.• Overseeing and coordinating the investigation of Non-conformities such as OOS & OOT• Investigating incidences of staff non-compliance with procedures.• Coordinating internal and external audits.• Assisting with evaluation of Nitrosamines and Genotoxic impurities.• Equipment/ Instruments qualifications• Ensuring compliance to Quality standards in R&D.

In charge of the QMS activities such as handling of investigations, deviations, Change Controls , Audit compliance, CAPA managements and responsible for ensuring the Quality Systems.• Maintaining the company’s SOP system.• Managing the R&D internal audit programme.• Ensuring that corrective action is taken to rectify any shortcomings.• Supporting the marketing, commercial and business development functions of the company.• Providing input into development protocols.

Mumbai Area, India

• Annual Product Quality Report (APQR): Accurately prepared Annual Product Quality Reports (APQR) of APIs to ensure Right First Time. APQRs were prepared in stipulated time to ensured minimum turnaround time (TAT).• Training Management: Identified training needs and conducted trainings on cGMP, GDP, GLP, Data Integrity (ALCOA+), Quality Assurance procedure to meet the quality requirements.

India

• Part of team which successfully faced various customer audits and regulatory audits such as MHRA and WHO.• Daily inspection of all Manufacturing lines to ensure compliance to Good Manufacturing Practices (cGMPs) and Standard Operating Procedures (SOP’s). Performed line clearance in class 10000 and 100000 environment.• Reviewed Batch manufacturing and Batch packing record for its completeness, accuracy prior to release of the manufacturing batch. • Prepared Process Validation… Show more • Part of team which successfully faced various customer audits and regulatory audits such as MHRA and WHO.• Daily inspection of all Manufacturing lines to ensure compliance to Good Manufacturing Practices (cGMPs) and Standard Operating Procedures (SOP’s). Performed line clearance in class 10000 and 100000 environment.• Reviewed Batch manufacturing and Batch packing record for its completeness, accuracy prior to release of the manufacturing batch. • Prepared Process Validation protocol as per SOP and reviewed executed Process Validation reports for accuracy, completeness and traceability. Show less

• Daily inspection of all Manufacturing lines to ensure compliance to Good Manufacturing Practices (cGMPs) and Standard Operating Procedures (SOP’s). Performed line clearance in class 10000 and 100000 environment.• Reviewed & approved executed batch records. Liaised between manufacturing & QA during batch record reviews.• Maintained QA logbooks for change control, instrument calibration schedules, instrument qualifications & technical reports and certificates of analysis.