Juned Shaikh Email & Phone Number

Mumbai Area, India

Quality and Compliance); Conduct internal audit of Quality Control for cGMP Compliance.•Conduct Audit of Different Contract Laboratory for cGMP Compliance.•Conduct Vendor’s Audit for different buyer locations.•Preparation of Audit Reports, monitoring their Compliance and timely closer of their observations.•Closely Monitor Stability Process, Method Development and Validations, Method Transfer, Cleaning Validation, Equipment Qualification and Verification and Lifecycle Management, Computerized System Validation, Risk Assessment, Purified System Validation, Environmental Monitoring, Microbiology.•Audit and compiling of Quality Metrix data and perform trend analysis.•Routinely Audited IPQC checks and GMP check rounds in manufacturing area with the objective of proactively addressing training needs. Provide training to shop floor personnel in IPQC unit with respect of Regulator aspects.•Looking after activity of Computerized System validation, inspection consideration for computerized system and data integrity with respect of Current Regulatory Requirements like GAMP 5, U.S. Code of FDA 21 CFR part 11 (ERES), U.S. Code of FDA 21 CFR part 210 & 211, EU Guideline for Data Integrity for Computerized system, U.S. Code of FDA 21 CFR part 820 (Quality System).•Review of validation plans, Test Plan and Validation summary report and test reports.•Monitoring Projects for plant level for their initiation and timely implementation.•Monitoring CAPA, Risk Assessments in Quality Control Lab. •Handling Quality systems like –Deviations, Quality Investigations, Change controls, CAPA, OOS, OOT, Trainings, Internal Audits, etc.•To ensure compliance against Regulatory observations and monitoring their response and effectiveness.•Monitoring Annual Product Quality Review, Market Complaints, and Quality Management Review documents.•Leading Project of Empower 3 validation and Implementation.

Aurangabad Area, India

Working as Deputy Manager in Quality and Compliance of Pfizer, Auangabad.

•Review of documents pertaining to Software Validation and GAP analysis of legacy systems, Annual Revalidation and Requalification documents.•Working on and bringing Culture of Compliance as per CQA and Regulatory Audit findings and recommendations as a part of Compliance Management and Office of Data Reliability Team.•Currently working on Audit findings of Regulatory Agencies and implementing the necessary changes and thereby bringing Culture of Compliance in routine working environment as part of Compliance Management team.•Working as a part of Remediation Team to bring overall compliance in Quality Control Department.Emcure, Pune; Quality Assurance-Compliance Cell; Given compliance to the Audit Observations-483 given by USFDA and their remediation by reviewing all the electronic data of HPLC, GC, Malvern, AAS and other systems and calculations and successfully cleared all the USFDA-483 observations.•Audit of Quality Control Laboratory for cGMP compliance and Quality Systems as per Internal Quality Audit and participation in External Audits.•Review and audit of electronic data related to computer systems used in Quality Control Laboratory.•Reporting of discrepancies, deviations and non-conformities to superiors. •Discussion of laboratory problems with Head-QA and assist in investigations.•Audit of quality control data and certificate of analysis.•Review of compliance verification to audit observations, laboratory investigations, market complaints and CAPA’s.•Review of SOP’s, standard calibration and validation documents, and procedures of QA and QC departments for cGMP Compliance.•Assist in regulatory compliance for FDA/customer audit/internal audit.•Evaluation of approved specification in line with current pharmacopeia wherever applicable.•Evaluation of product quality review and trends.•Control of SOP’s, standard calibration, validation and procedures of QA and QC departments. Pfizer, Aurangabad

Reviewing of documents pertaining to Method Validation and Verification, SOP’s and Change Control, Handling of Deviation, OOS and OOT, carrying out Investigation Plan and Shop Floor Investigation, raising CAPA.•Review of commercial stability documents of ANDA’s filed in US of each stability station, deviations, OOS and OOT observed in those documents and giving compliance to the Office of Data Reliability by providing necessary inputs and documents.

Sultanate Of Oman

•Performed Method Development and Validation of Active Pharmaceutical Ingredients (API’s) on modern instruments like HPLC, GC, LCMS and GCMS and familiar with USP, NF, BP, AOAC, BPC and JP requirements. •Solved queries related to Method Validation from EDQM and other Regulatory Agencies; Compliance Management and Office of Data Reliability Team)