MOHD NAVEEDUDDIN MUSA

Contact: +918341803430 | Email: mohdnaveeduddinmusa@gmail.com

https://www.linkedin.com/in/chaitanya-sasank-mulpuri-987b9176/

TARGET ROLES: QUALITY ASSURANCE SPECIALIST

Offering 9 years of insightful professional experience
Domain Exposure: Pharmaceutical Injectable & Vaccines

 High-performing, results-driven Quality Assurance professional with hands-on experience across all facets of quality
assurance and validation in the domain of sterile formulations, encompassing vials, lyophilized vials, pre-filled
syringes (PFS), blow fill seals (BFS), form fill seals (FFS), and vaccines.
 Possessing extensive industry experience and an in-depth understanding of the pivotal elements crucial for ensuring
the safety and efficacy of products.
 Exemplary analytical skills; known for having led successful major regulatory audits like USFDA, ANVISA, WHO, MCC,
INFARMED and Health CANADA.

Expertise in: Validation Protocol & Reports | Cleaning/Process Validation | Aseptic Media Fill Validations |
Quality Management Systems (Deviations, Change controls & CAPA ) |Project Execution | Quality Assurance & Compliance |
SOPs | Resource Optimization | Gap Assessments | Regulatory & Statutory Compliances | Cross-functional Team
Collaboration

Profile Summary

 Profile: Offering demonstrable research and quality management skills with an analytical mindset to achieve strategic objectives of
the organization and contribute to overall organizational growth and profitability.

 Expertise: Adept in crafting, planning, and executing all equipment validations like Autoclave, Washing Machine, Sterilization
and Depyrogenation Tunnel, Filling Machine, Sealing Machine, Lyophilizer, Terminal Sterilization, Bio-Decontamination
Validations, HVAC, Water System Qualifications and QC equipment thermal validation, ensuring resource availability, workforce
allocation and team mentoring.

 Experience: Experienced in analysing information quickly & using it for validation Master plan updation, batch record review and
inprocess quality assurance.

 Proficiency: Exceptional record of accomplishment in review and approvals of System impact assessments, URS, Design
qualification, Risk assessments, Traceability matrices, Commissioning / SAT / IOQ, PQ and RQ protocols and reports, review of gaps
through periodic system review and review of corrective and preventive action for their effectiveness and batch record review for
batch release and inprocess quality assurance for product manufacturing.

 Technical Skillset: Yokogawa data logger software for F0, SLR and SAL calculation, Ebro Datalogger software for temperature
mapping studies, Metric Stream for all Quality Management related activities.

 Proven Leadership Attributes: Delivering the best possible results for the organization and showing determination,
resourcefulness, and a sense of purpose; seeking commitment from different quarters to benefit the organization. Excellent
interpersonal, communication and organizational skills with proven relationship management and business communication
abilities.

Career Contour

Sanofi Healthcare India Pvt. Ltd., Location: Medchal

Associate (L1-1 grade) November 2021 onwards

Key Result Areas:

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 Developed qualification/validation protocols, plans, and reports, ensuring adherence to established standards and guidelines.
 Oversaw the review and approval of commissioning, SAT, IOQ protocols, and reports for new projects involving utilities, HVAC,
equipment, and cleaning validation.
 Verified and sanctioned qualification and validation documents (URS, SIA, DQ, IQ, OQ, PQ) for equipment, utilities, and systems,
ensuring compliance with regulatory requirements.
 Monitored and supervised various validation activities such as cleaning, sterilization and bio-decontamination validation, and
water system qualifications, maintaining the integrity of processes and systems.
 Actively participated in qualification activities for new projects, contributing to the successful implementation and validation
of critical processes.
 Developed and maintained standard operating procedures, and managed the validation-related quality management system,
fostering consistency and compliance throughout the validation process and promoting operational efficiency.

Noteworthy Contributions:
~ Resolved aseptic process simulation failure during the centrifuge and inactivation stage by implementing an enhanced cleaning
procedure in collaboration with the R&D team, enabling the completion of simulation and resuming routine manufacturing.
~ Achieved zero deviations during the commissioning and qualification of the purified water storage and distribution system by
deploying QA personnel to monitor activities on the service floor and shop floor, ensuring thorough execution and successful
completion of the project.
~ Devised and effectuated a new Bio Safety Level (BSL)-2 area qualification protocol in collaboration with the manager and R&D
team, completing the qualification for the Hep-A manufacturing area and enabling its release for routine manufacturing
operations.

Jodas Expoim Pvt. Ltd., Location

Executive from Mar 2018 – May 2019
Noteworthy Contributions:
~ Framed qualification and validation protocols and reports, ensuring compliance with regulatory requirements and industry
best practices.
~ Calculated cleaning validation MACO/MAR limits using multiple approaches (toxicological/health-based, dose-based, and
10ppm) to ensure safe and effective cleaning procedures for manufacturing equipment.
~ Eliminated the number of deviations and observations during third-party audits to zero by implementing review and approval
of processes by the Jodas QA team for process and cleaning validation protocols at third-party manufacturing sites.
~ Implemented a new procedure for dose-based Maximum Allowable Carryover (MACO) limit calculation for cleaning validation
studies, ensuring compliance with current industrial and regulatory standards and enabling effective execution of cleaning
validation across all products.

Aurobindo Pharma Limited UNIT – IV, Location

Executive, Feb 2013 – Mar 2018
Noteworthy Contributions:
~ Designed and implemented a new sampling plan for cleaning validation, enabling clear attribution of data; This
implementation resulted in more reliable and attributable data during cleaning validation, facilitating effective failure
investigations.
~ Deployed a new format for writing cleaning validation protocols, incorporating clear objectives, scope, and validation plans,
while integrating data generated from eResidue software; eliminated observations related to cleaning validation protocols to
zero during audits.
~ Calculated cleaning validation MACO/MAR limits using multiple approaches, including toxicological/health-based (ADE/PDE),
dose-based, and 10ppm, ensuring safe and effective cleaning processes.
~ Developed comprehensive process validation protocols and reports for diverse product types, such as vials, ampoules, pre-
filled syringes, blow-fill seals, form-fill seals, and lyophilized products.
~ Created aseptic process simulation validation protocols and plans for vials, ampoules, pre-filled syringes, blow-fill seals, and
lyophilized products.
~ Successfully conducted aseptic media fills in coordination with production, ensuring the integrity and sterility of the
manufacturing environment.

Education & Certification

Bachelor’s in Pharmacy, Gokaraju Rangaraju College of Pharmacy, Hyderabad, Telangana.

Lean Six Sigma Green Belt Certification, 2022

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