Shaik Shahena Begum

As a Quality Assurance and Medical coding compliance professional with 4.7 years of experience in pharmaceutical manufacturing, ensuring GMP compliance and adherence to regulatory standards. Skilled in process validation, cleaning validation, internal audits, deviation management, and change control, with expertise in reviewing batch records for mRNA, parenteral, and solid oral dosage forms. Proficient in medical coding, including Emergency & E&M outpatient coding, HCC ICD coding, and CPT coding.

Strong analytical abilities with a focus on accuracy in coding and documentation. Experienced in root cause analysis, risk assessment, internal audits, product quality reviews, process validation, cleaning validation, IQ, OQ, PQ, and URS development. Technically proficient in MS PowerPoint, MS Word, MS Excel, Power BI, and Basic Python.

Excellent verbal and written communication skills, with the ability to collaborate effectively in cross-functional teams. A quick learner with a commitment to delivering high-quality outcomes in dynamic environments.

Quality Assurance specialist I at Siegfried (2025-08 – Present)

• Performed final QA review and approval of materials, including APIs, intermediates, and controlled substance packaging components in compliance with cGMP and regulatory requirements.
• Authorized release of quarantined materials for distribution after thorough documentation and compliance verification.
• Conducted label verification and approval to ensure accuracy, traceability, and adherence to approved specifications and regulatory standards.
• Reviewed and approved Certificates of Analysis (CoA) in accordance with established SOPs and quality standards.
• Executed detailed batch record review (BMR/BPR) and cleaning record verification, ensuring completeness, accuracy, and data integrity.
• Provided QA oversight for laboratory and manufacturing suite clearances, confirming readiness for operations and compliance with cleaning procedures.
• Compiled and prepared Annual Product Reviews (APR/PQR), including trend analysis, deviation summaries, and process performance evaluation.
• Managed controlled document destruction in alignment with SOPs and data integrity requirements.
• Supported and participated in internal audits, contributing to audit readiness and continuous quality improvement initiatives.
• Performed QA review and approval of shipping and batch release documentation, ensuring compliance with regulatory and company standards prior to distribution.
• Maintained adequate inventory of label stock through routine monitoring and initiated label reordering to prevent stockouts and ensure uninterrupted operations.
• Managed printer supply inventory, including toner, ribbons, and other consumables, to support continuous label printing activities.
• Oversaw the administration of label management systems/software, ensuring all label templates and revisions met regulatory and quality requirements.
• Issued, tracked, and maintained controlled documents, such as batch records, SOPs, and protocols, in compliance with document control procedures.
• Executed document archival activities, including coordination with off-site storage vendors, and ensured proper retrieval and secure storage of critical GMP records.
• Applied version control procedures and managed document lifecycle workflows using industry-standard systems (e.g., MasterControl, Trackwise) to maintain data integrity and regulatory compliance.
• Reviewed process validation and cleaning validation studies documents to ensure the consistent production of high-quality products that meet predetermined specifications.
• Performed internal audits to assess compliance with GMP regulations and identify areas for improvement.
• Investigated deviations and implemented Corrective and Preventive Actions (CAPA) to address root causes and prevent recurrence.
• Managed change control processes to evaluate and approve proposed changes to products, processes, or equipment.
• Participated in product quality reviews to assess product performance, identify trends, and recommend improvements.
• Provided training to personnel on GMP principles, quality procedures, and other relevant topics.
• Reviewed batch records for mRNA products, parenteral preparations, and solid oral dosage forms to ensure compliance with SOPs and regulatory requirements.
• Performed line clearance activities to verify the cleanliness and readiness of manufacturing areas.
• Managed deviations and investigations, identifying root causes and implementing corrective and preventive actions (CAPA).
• Participated in change control processes, assessing the impact of changes on product quality and compliance.
• Contributed to the continuous improvement of quality systems and processes.
• Proficient in using Electronic Data Management (EDM) systems for data review and analysis.
• Demonstrated expertise in buffer preparation, media preparation, and aseptic techniques.
• Performed inspections and in-process checks in ISO-classified cleanroom environments, ensuring compliance with aseptic techniques and GMP standards.
• Monitored gowning procedures, personnel flow, and hygiene practices to maintain contamination control and support production quality.
• Supported cleanroom sanitisation, line clearance, and documentation review, contributing to consistent batch integrity and regulatory compliance.

Quality Assurance Specialist at Saayam For All (2025-05 – 2025-08)

• Supported QA project planning, task tracking, and timeline management to ensure on-time completion of quality activities.
• Coordinated QA meetings, prepared documentation, and followed up on action items.
• Tracked QA deliverables, identified risks or delays, and escalated issues to QA leadership.
• Maintained controlled quality documentation in compliance with GMP requirements.
• Updated QA dashboards and used tracking tools to monitor quality metrics and project status.

Healthcare Assistant at Omega Healthcare Management Services (2022-07 – 2023-08)

• Led coding for Emergency and E&M outpatient services, ensuring accurate application of ICD-10-CM and CPT codes.
• Reviewed and verified medical documentation, maintaining high standards of quality and compliance.
• Provided guidance and expertise to other coding staff, improving team productivity and accuracy.
• Identified documentation deficiencies and recommended corrective actions to enhance coding accuracy.

Clinical documentation at Doctus Data Services Pvt Ltd (Worked for Change Healthcare) (2021-04 – 2022-07)

• Performed E&M outpatient coding and HCC ICD coding, ensuring high accuracy and compliance.
• Maintained adherence to HIPAA guidelines and confidentiality protocols.
• Collaborated with healthcare providers to clarify and correct documentation issues, improving reimbursement processes.

Associate – Ops at WNS Business Consulting Services Pvt Ltd (2019-09 – 2021-03)

• Analyzed and coded Emergency and procedural medical records using ICD-10-CM codes.
• Supported diagnostic procedures by reviewing patient records and ensuring coding accuracy.
• Ensured compliance with industry standards, providing feedback to improve coding practices.

Master of Science in Health Informatics – New England College (2023-08 – 2025-03)

Bachelor of Pharmacy – Yalamarty Pharmacy College, Andhra University (2015 – 2021)