Golkonda Ahammad Basha
Hyderabad
Summary
Results-driven Quality Assurance Manager with a strong background in compliance and quality improvement. Proven analytical skills support effective audit preparations and vendor qualifications. Experienced in global team collaboration and training initiatives that align with regulatory standards.
Overview
18
18
years of professional experience
Work History
Manager - Site Quality Assurance (QA)
Vasudha Pharma Chem Limited
Hyderabad
12.2025 - Current
- Managed Change Control process, evaluated and approved changes to processes, equipment, raw materials, and systems, ensuring compliance through regulatory impact assessments.
- Led customer and regulatory audit preparations, managing responses and remediation activities for audit citations to maintain compliance and improve site readiness.
- Reviewed all Quality Management System (QMS) related documents including deviations, change control, complaints, return goods, out of specification (OOS), out of trend (OOT), incident investigation reports, site master file (SMF), and annual product quality reviews (APQRs) according to standard operating procedures.
- Reviewed Quality risk management reports to identify potential issues and ensure adherence to quality standards.
- Handling vendor qualifications and assisting the CQA team to perform vendor audits.
- Review of protocols and reports for Prospective & Concurrent validations.
Manager - Corporate Quality Assurance (CQA)
Vasudha Pharma Chem Limited
Hyderabad
03.2018 - 12.2025
- Schedule, plan, organize, and execute the Corporate Quality Internal Audits at Vasudha Manufacturing sites. (Total 6 No) and also perform desktop Audits, For cause audits, surprise audits, and Data Integrity audits.
- Schedule, plan, organize and perform the vendor on-site/Virtual/Desktop audits and preparation of audit reports, follow up noncompliance and its CAPA, agreements for API, KSM, Advance Intermediates, Primary packing material, Contract manufacturers, Contract Testing Laboratories and Service providers throughout the Vasudha group.
- Executed activities to enhance compliance levels at sites, ensuring alignment with quality standards and regulatory requirements.
- Coordinated customer and regulatory audits, managing response and remediation activities for audit citations related to corporate quality procedures and site systems.
- Prepared, reviewed, and approved corporate quality assurance standard operating procedures (SOPs) and conducted training across the organization.
- Contributed to operational and quality improvement initiatives and projects to enhance overall quality standards.
- Review of all Quality Management System (QMS) related documents such as Deviations, Change Control, Complaints, Return Goods, OOS, OOT, Incident investigation reports, Site Master File (SMF), and APQRs as per SOPs & Regulatory guidelines.
- Review, assessment, and approval of Corporate Change Controls.
- Review of Process Validation Protocol, Reports, and Cleaning Validation Reports.
- Review of Equipment qualifications and utility Qualifications like HVAC and Water system documents.
- Review of Computer System Validations (CSV) documents.
- Organize and impart the cGMP training, On the job, Core SOPs training and technical aspects at Hyderabad units.
- Participate in monthly review meetings (MRM/BRM) and execution of Core Quality Minutes as per discussion with top/middle management.
Sr. Executive - Site Quality Assurance
Sai Life Sciences Ltd.
Hyderabad
12.2014 - 02.2018
- Handling of Vendor / Service providers Qualification activities and performing the audits and filling of Customer Questionnaires.
- Organized and imparted cGMP and job training at the site level.
- Prepare employee training need matrix, annual schedules of cGMP and job training.
- Actively participate in Change Control review and its effectiveness evaluation.
- Review of protocols and reports for Prospective & Concurrent validations.
- In-process monitoring while execution of validation batches.
- Handling of deviations (Controlled and Uncontrolled), Identifying root cause and implementing corrective and preventive actions and reviewing for their effectiveness.
- Line clearance for manufacturing areas during batch-to-batch and product changeover.
- Coordinated activities with quality control, warehouse, supply chain management, and production teams to ensure smooth operations.
- Responsible for reviewing executed batch production records, batch cleaning records and connected relevant documents before product release.
- Active participation in audits (Customer, Regulatory and Corporate QMS audits).
- Responsible for Monitoring clean rooms.
Sr. Assistant (S2) - Site Quality Assurance
Aurobindo Pharma Limited
Hyderabad
03.2010 - 12.2014
- Review of protocols and reports for Prospective & Concurrent validations.
- In-process monitoring while executing validation batches.
- Coordination in product return goods and its salvage procedure.
- Coordination in the Market complaint along with the QA Manager.
- Handling of deviations (Controlled and Uncontrolled), Investigation of Deviations, identifying root causes and implementation of corrective and preventive actions and reviewing for their effectiveness.
- Preparation and review of Annual Product Review reports.
- Active participation in Dispatches as per QA release procedure.
- Responsible for review of executed batch production records, batch cleaning records and connected relevant documents before the release of the product.
- Supervision for Sampling of Raw Materials, API and Intermediates.
Assistant Officer - QA & QC
Nectar Laboratories Limited
Bollaram
09.2008 - 03.2010
- IPQA activities
Education
M.Sc. - Biochemistry
Acharya Nagarjuna University
Guntur, Andhra Pradesh01-2008
B.Sc. - B.Z.C
Acharya Nagarjuna University
Giddalur, Prakasam01-2003
Skills
- Quality assurance standards
- Analytical troubleshooting
- Tech learning eagerness
- System adaptability
- Commitment to results
- Global team collaboration
- Presentation skills
- Verbal communication
- Interpersonal skills
- Quick learner
- Work ethic
Audits Faced
- Participation in Regulatory audits to get the approval of USFDA, EDQM, PMDA, MHRA, TGA, ANVISA, RU GMP, CFDA and COFEPRIS.
- Faced various global customer and third-party audits.
Existing Ctc
13,00,000 INR
Performed Audits
- Performed around 100+ on-site/desktop/Virtual real-time remote vendor audits (API, KSM, Advance Intermediates, Packing material, Contract Manufacturers, Contract Testing Laboratories and Service Providers)
Languages
- English
- Hindi
- Urdu
- Telugu
Personal Information
- Date of Birth: 06/10/83
- Nationality: Indian
- Marital Status: Married
Disclaimer
I hereby declare that the above-furnished information is true to the best of my knowledge. I would adhere to the rules and norms of your organisation.
Training Programs
- Concept, principles, strategy & approach for managing internal & external audits, 2 days, Hotel Radison, Hyderabad, India
- QMS Auditor/Lead Auditor, Udemy
- Handling of Human Errors, Dr. M. Damodharen
- CGMP online workshop for pharmaceutical units in API & Formulations, 06/14/21 to 06/21/21
Personal Traits
- Excellent analytical and troubleshooting skills.
- Strong verbal and written communication skills.
- Ability to work effectively with global, virtual teams.
- Good interpersonal & presentation skills.
- Auditing skills.
Timeline
Manager - Site Quality Assurance (QA)
Vasudha Pharma Chem Limited
12.2025 - Current
Manager - Corporate Quality Assurance (CQA)
Vasudha Pharma Chem Limited
03.2018 - 12.2025
Sr. Executive - Site Quality Assurance
Sai Life Sciences Ltd.
12.2014 - 02.2018
Sr. Assistant (S2) - Site Quality Assurance
Aurobindo Pharma Limited
03.2010 - 12.2014
Assistant Officer - QA & QC
Nectar Laboratories Limited
09.2008 - 03.2010
M.Sc. - Biochemistry
Acharya Nagarjuna University
B.Sc. - B.Z.C
Acharya Nagarjuna University