Senior Pharma Quality Assurance (API and Bulk Drugs): Flawless GMP, Auditing, cGMP, Regulatory, and QMS Documentation

Expertise

• Compliance to cGMP Systems and Regulatory requirements.
• Application risk assessment, as applicable at various QMS documentation.
• Review of all the SOPs, batch production records and protocols (validation and qualifications) prior to the approval along with change request forms.
• Review of all equipment qualification documents like reactors, centrifuges, different types of dryers, blenders, powder process equipment etc., (DQ, IQ, OQ, PQ) and related test reports.
• Review of clean room HVAC qualification documents and related test reports.
• Review of purified water system qualification documents and related test reports.
• Review and approval of annual product reviews.
• Providing training in quality systems and procedures to the competent level.
• Act as a representative during regulatory audits and customer inspections to co-ordinate with the Inspectors and auditors.
• Ensuring compliance to latest guidlines: GMP; GLP; 21CFR PART 11; 21CFR PART 210 & 211; EUGMP Annex 11, DSchedule M, WHO and other international guidelines, as applicable.
• Perform internal quality audit reviews as per the schedules.
• To schedule, conduct vendor audits and co-ordinate with purchase department for conducting vendor audits.
• Follow up of CAPA or compliance activity from vendors for the audits already done.
• Coordinate with all the departments while investigating the product non-conformances, Market Complaints and Returned goods.
• Releasing or Rejecting of all APIs and Intermediates.
• Coordinating with concerned departments during development of products for plant scale and handling process control parameters.
• Preparation and issuance of BMR/ BPR (Batch Manufacturing Record and Batch Packing Records).
• Preparation of SMF, (Site Master File).
• Prepare monthly reports, training slides, gather quality data.
• Preparing quality trends, yield assessment reports.
• Effective documentation control by systematically organizing documentation, storage and retrieval.
• Handling of Change Control System, Deviations, Out of Specifications and Out of Trends.
• Trainings; Induction/On Job/cGMP training and other areas.
• Issuance/retrieval of SOPs, Specifications, STPs etc.
• Review of batch records and analysis data of vendors to ensure compliance with systems and procedures.
• Keep a track of changes in process, deviations and complaints for the materials supplied by vendors and suggest corrective and preventive measures during and after completion of vendor audit.
• Review technology transfer and validation documents for APIs and Intermediates and participate in transfer of technology and validations at vendor's site.
• Handling of Vendor Approval System/Approved vendor List/Vendor Assessment Questionnaire
• Conducting internal audits and handling of non compliance during internal audits.
• Review technology transfer and validation documents for APIs and Intermediates and participate in transfer of technology.
• Preparation and Review of all types of validation protocols, summary reports.

Audits-Licensing & Assurance

• Lead quality assurance department in API unit with a sub-ordinate team of approximately 40 people.
• Lead auditee in more than 500 customer audits (API) and around 10 regulatory audits.
• Lead auditee for USFDA at various times providing over a decade of auditing.
• Auditee for EUGMP regulatory
• Auditee for PMDA regulatory
• Auditee for KFDA regulatory 
• Annual licensing applications (manufacturing, GMP, schedule M) for Indian drug control department (DCGI) and consequently acted as auditee for certification for more than 20 audits.
• Auditee for CDSCO and WHO GMP , (10 count).

Experience

Rakshit Pharmaceutical Ltd, Visakhapatnam, India, AGM - Quality Assurance, Feb 2023 - Sept 2024

• Overall responsible for all Quality Assurance Activities (Head of the
  department) for API manufacturing site which includes handling of site QA
  activities, handling of customer audits and various regulatory audits. 
• Responsible for overall compliance to applicable GMP norms.
• Responsible for round-the-clock audit readiness to any regulatory authority

P.F.C.P. Ltd., Bangalore, India, Sr. Manager, Quality Assurance, 2019 - 2022

• Implementing GMP in line with 21 CFR part 210 & 211, ICH, Schedule M and as per customer's specific regulatory agency.
• Ensure computerized systems are adhere to 21 CFR part 11.
• Coordinate and conduct verification of documents generated during manufacturing for adequacy, accuracy and authenticity.
• Analyze observations in order to compliance to cGMP systems and regulatory requirements.
• Review of all the SOPs, Batch Production Records and Protocols (Validation and Qualifications) prior to the approval along with change request forms.
• Review and Approval of Annual Product Reviews (APR / APQR)
• Guide and motivate the employees by providing training in quality systems and procedures to the competent level.
• Releasing or Rejecting of all APIs and Intermediates.
• Documentation for cleaning room validation and qualification
• Implement documentation system to develop, maintain, distribute and control all Quality Control, Quality Assurance, (QC-QA), production, maintenance and warehouse records.
• Act as a Plant Representative during regulatory audits and customer inspections to co-ordinate with the inspectors and auditors.
• Approve or reject proposed new sources of supply of raw materials and packaging components on basis of QC results and/ or Vendor audit.
• Coordinate with all the departments while investigating the product non-conformances, market complaints and returned goods.
• Perform internal quality audit reviews and vendor audits as per the schedules.
• Cleaning validation and process validation.
• Ensure cleaning validation meets current guideline requirements like APIC (Active Pharmaceutical Ingredients Committee, EUdra, (European Union Drug Regulatory Authorities), etc,.
• Review and approval of MACO, (Maximum Allowable Carryover) risk assessment documents.
• Review and approval of toxicology study documents for API.
• Comply to ICH Q3D, NDMA and applicable nitrosamine guidelines, (ICH M7).
• Investigate the reasons for the deviations and provide the effective corrective and preventive actions in order to prevent recurrence.
• Review and coordinate in concluding the out of specification in the Quality Control area and manufacturing area,
• Handling of Failure investigations
• Ensure QMS (quality Management system) is up-to-date and comply to current GMP requirements.
• Respond to regulatory queries

SMS Pharmaceuticals Ltd, Visakhapatnam, Inda: Sr. Manager-Quality Assurance, 2018 - 2019

• Head of the department-quality assurance.
• Handing customer and regulatory audits.
• QMS (Quality Management system).
• Respond to customer queries.
• Respond to regulatory queries.
• Change control system.
• Deviation system.
• Out of specifications.
• Failure investigations.
• Handling customer complaints and market complaints.
• Review and approval of SOPs (standard operating procedure).
• Implement GMP.
• Implement 21 CFR Part 11.
• Process Validation
• Cleaning validation and process validation.
• Ensure cleaning validation meets current guideline requirements like APIC, EUdra etc,.
• Review and approval of MACO, risk assessment documents.
• Review and approval of toxicology study documents for API.
• Comply to ICH Q3D, NDMA and applicable nitrosamine guidelines (ICH M7).

Wanbury Limited,Tanuku, Andhra Pradesh, India, Manager-Quality Assurance, 2011 - 2018

• Handing customer and regulatory audits.
• QMS (Quality Management system).
• Respond to customer queries and regulatory queries.
• Change control systems.
• Deviation systems.
• Out of specifications.
• Failure investigations.
• Handling customer complaints and market complaints.
• Review and approval of SOPs (standard operating procedure).
• Implement GMP inline with 21 CFR part 210 & 211.
• Implement 21 CFR Part 11.
• Process validation and cleaning validation.
• Ensure cleaning validation meets current guideline requirements like APIC, EudraLex etc,
• Review and approval of MACO, risk assessment documents.
• Re view and approval of toxicology study documents for API.
• Comply to ICH Q3D, NDMA and applicable nitrosamine guidelines (ICH M7).
• Handling Indian drug control certification documents (DCGI).
• Handling CDSCO certification and CDSCO, (Central Drugs Standard Control Organization) audit.
• Handling local FDA GMP audits.
• APQR and APR (Annual Product Quality Review).
• Quality trending.
• DM water, (Drinking Water) and purified water qualification and its documentation.
• Documentation for cleaning room validation and qualification.
• Batch release.
• Equipment qualification.
• Training to all departments on GMP.

Azico Pharmaceuticals Pvt., Ltd, Visakhapatnam, India, Division Manager-Quality Assurance, 2013 - 2014                                     

• Handing customer and regulatory audits.
• QMS (Quality Management system).
• Respond to customer queries.
• Respond to regulatory queries.
• Change control system.
• Deviation system.
• Out of specifications.
• Failure investigations.

Lupin Limited, Bhopal, India, Quality Assurance Chemist (Grade E1), 2010 - 2011

• IPQA (In process quality assurance).
• Batch release.
• BMR review.

Hetero labs Limited, Khajipally, Andhra Pradesh, India: Executive: Quality Assurance, 2007 - 2010

• Handing customer and regulatory audits.
• QMS (Quality Management system).
• Respond to customer queries.
• Respond to regulatory queries.
• Change control system.
• Deviation system.
• Out of specifications.
• Failure investigations.
• IPQA
• Documentation for cleaning room validation and qualification.

Srini Pharmaceuticals (Pvt) Ltd, Choutuppal, Telengana, India, 2005 -2007

• Quality Assurance Chemist
• IPQA (In process quality assurance).
• Batch release.
• BMR review.

Honors & Publications

Languages 

• English (Fluent)
• Hindi (Fluent)
• Telugu (Native)

Education

• M.Sc Chemistry, Acharya Nagarjuna University, Andhra Pradesh, India
• B.Sc Chemistry, Acharya Nagarjuna University, Andhra Pradesh, India