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

Technical Consultant #2585


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.
  • 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.
  • Documentation for cleaning room validation and qualification
  • Effective documentation control by systematically organizing documentation, storage and retrieval.
  • Handling of 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

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

     

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