Subhas Nayak Email & Phone Number

Dubai, United Arab Emirates

Dubai, United Arab Emirates

● Maintaining Quality records on product testing, nonconformance, project outcomes, and stakeholder input filed in an accurate and timely manner. ● Making proposals and assist in the development of Corrective Action plans and monitors implementation. ● Managing Change Control documentation and approval process ● Following up and documenting closure of corrective and preventive actions. ● Collecting and analyzing information from different quality management systems to support in the QMS periodic review process. ● Assess current quality systems, perform risk assessment and recommending improvements in order to enhance quality and reduce cycle time ● Prepare for and facilitate internal audits (JJRC) and regulatory/corporate inspections. ● Managing annual distributors/suppliers qualification. ● Support and cooperate in the implementation of the Middle East Field safety Corrective Actions systems. ● Monitor trends, identify issues, recommend and implementing appropriate actions. ● Assisting in the development, implementation and review of standard operating procedures for Synthes UAE Distribution Center (Involved in Loaner Kit Operations) and Technical Services Center, DAFZA. ● Member of Loaner Kit CoP and Installation & Service CoP. ● Active participation in MOH UAE Audit, JJRC at Technical Services Center, DAFZA. ● Performing Gemba Walks at Synthes UAE DC and Technical Services Center, DAFZA, Dubai

Abu Dhabi, United Arab Emirates

● Performing efficient IPQA for tablet products. ● Performing sampling of In-process, finished products in production and sampling as per the approved validation protocol for validation batches. ● Monitoring of compliance, meeting the requirements of cGMP. ● Providing training to operators/workers. ● Verifying Installation Qualification/Operational Qualification/Performance Qualification status of equipments. ● Assisting in Performance Qualification for production equipments and Process Validation studies. ● Reviewing and approving the Excess Material Return Note, Online Rejection Note and Finished Goods Transfer Note. ● Reviewing and approving the batch documents for further processing. ● Providing online coding approvals. ● Compilation and updates for APQR. ● Generating daily and up-to-date IPQA activity report and providing the same to the Quality Assurance Head. ● Successfully faced MHRA, EU-GMP, ANVISA.

Bengaluru, Karnataka, India

● Person in plant (PIP) for Hyderabad and Bangalore based Contract Manufacturing sites - MSN -Laboratories, Recipharm, Wintac, Vital Therapeutics and Unique Biotech.● To ensure cGMP compliance and timely closure of Quality Management System (QMS) events at each Contract Manufacturing Sites (CMS).● Co-ordination with manufacturing sites for batch execution, testing and it's release by reviewing documents like BMR/BPR, Process Validation report, stability report, Specification/Standard Testing Procedure, Certificate of Analysis and approval of Certificate of Conformance for dispatch of drug product from CMS.● Troubleshooting of various quality events and coordination with Contract Manufacturing QA.● Active participation in failure/ market complaint investigation at CMS and suggest proper resolution.● Tracking of all open QMS events like Corrective Action Preventive Action, deviations, complaints etc. related to CMS products and preparation of periodic quality matrices and escalation for open actions.● Execution, monitoring and review of Process validation at CMS.● Qualification/ Requalification of CMS, ensuring Technical agreement sign off and compliance to Technical Agreement.● Establishing quality system framework for Mother Warehouse, ensuring Current Good Warehouse Practice compliance is in line with Standard Operating Procedure (SOP) and regulatory guidelines.● Ensure the collection, storage and annual inspection of control samples of every receipt batch at warehouse.● Performing the Packed Stock Verification, Collection of analysis samples and submission to Contract Testing Laboratory with Test Request Form.

Bengaluru, Karnataka, India

● Experienced in IPQA, BMR issuance, online coding approvals. ●Performing efficient IPQA for Oral Solid Dosage forms. ● Assuring the production of tablets is in compliance to specification mentioned in Batch Manufacturing Record. ● Expertise in Documentation, Technical Reporting. ● Understanding of Master Manufacturing Formula and Production Assurance as per standards.

Master'S Degree, Pharmaceutics And Drug Design

M. Pharm

Bachelor Of Pharmacy (Bpharm), Pharmaceutical Sciences

Activities and Societies: Students' Union Council (Cultural Secretary). Cricket, Volleyball, Football. B.Pharm

Pre-University, Biology/Biological Sciences, General

High School

Primary, Primary