Quality Assurance Operations Manager

Quazi Hoque

(Cherry Hill, NJ; available to work remote)

Summary:

• Quality Management Leader with a proven record working in multiple scenarios in the pharmaceutical industry.

• Quazi presents a compelling profile for the Quality Assurance Operations Manager position, with a robust background in Quality Assurance (QA) within the pharmaceutical industry. His experience spans over a decade; experience aligns well with the job's requirement for a candidate who can execute quality oversight of external manufacturing, both clinical and commercial drug product through lot disposition.

• Quazi's role in reviewing, investigating, auditing, and releasing products underscores their capacity to provide QA review and approval of internal and external Deviations, Change Controls, CAPAs – key responsibilities of the role. His hands-on experience with regulatory requirements and guidelines, alongside their role in ensuring product quality and compliance, mirrors the job description's emphasis on meeting cGMP regulatory requirements and guidelines.

• Performed review of product batch records relating to drug substance and aseptic/sterile processing ensuring all products released are within compliance of regulations and company policy and procedures.

• Quazi's extensive QA background in drug manufacture validation suggests a foundational skill set relevant to the operational aspects of the role. His experience with regulatory compliance, combined with a proactive approach to quality assurance and risk mitigation, positions him as a strong candidate capable of supporting the continuous improvement and compliance efforts required by the position.

• Performed qualification, for cause and routine cGMP external and internal audits for clinical and commercial drug substance and drug product manufacturing processes for various pharmaceutical companies.

• Write and review SOP, follow up and investigate complaints of any QA related issues; Work with other QA functional areas to ensure the change control, deviations, CAPA’s, incidents, atypical, etc. reports are reviewed and approved as appropriate.

• Experience of first hand GMP management & exposure to FDA / EMA / PMDA / ANVISA or other authorities of similar standing. Education

Djambul Engineering Institute, Kazakstan, USSR

Bachelor’s Degree in Electrical Engineering

Comilla Polytechnic Institute, Kotbari, Comilla, Bangladesh Electrical Engineering/ Diploma

NKM High School, Comilla, Bangladesh

Secondary School Certificate

Skills

• Proficient in the use of the automatic weight variation equipment disintegration apparatus, moisture analyzer, hardness tester, friabilitor, bulk density tester.

• Proficient in PC based MS Word and Excel, Dos windows, Database, Internet and Power point.

• Proficient in ERP Systems (SAP, QMS & Trackwise) and Veeva system

Professional Experience:

Merck Oct 2024 –

Present

Quality Assurance Compliance Specialist (Contract)

• Preparation and completion of the Annual Product Quality Review

(APQR) to assess product performance and compliance.

• Investigating, reviewing, and approving deviations and excursions, ensuring proper documentation and resolution in alignment with regulatory requirements.

• Overseeing the use and management of QMS for efficient tracking of quality events and corrective actions.

• Providing oversight for Document Control, Change Control, and Deviation Management to maintain compliance and product quality.

• Conducting internal and external audits, ensuring adherence to regulatory standards, and managing laboratory controls and complaints resolution.

• Managing reprocesses, recalls, and supplier qualification activities to ensure product safety, quality, and regulatory compliance.

• Leading Environmental Monitoring programs to ensure compliance with industry standards and environmental health and safety.

• Delivering GMP training to staff to ensure ongoing compliance with Good Manufacturing Practices.

• Supporting management reviews with monthly Key Performance Indicator (KPI) reports to drive continuous improvement and operational excellence.

Aurobindo Pharma, Dayton,

NJ Jul 2019 – Sep 2024

Sr. Quality Assurance Specialist

• Performed data/document reviews, investigate/resolve non- conformances, and maintain change control systems.

• Ensured company adherence to Good Manufacturing Practices

(GMPs), Good Documentation Practices, applicable regulatory standards, and internal procedures and practices.

• Validated products and equipment, follow IQ, OQ, and PQ standards, and calibrate equipment.

• Produced R&D batches to improve the product quality on SAP and perform stability studies for to see the change control effectiveness.

• Performed review of product batch records relating to drug substance and aseptic/sterile processing ensuring all products released are within compliance of regulations and company policy and procedures.

• Worked with Contract Manufacturing Organizations (CMOS) & other QA functional areas to ensure the deviations, CAPA’s, incidents, atypical, out of spec, variants, etc. reports are reviewed and approved as appropriate.

• In-house auditing, external auditing, and hosting the client auditing, as well as responding to audit comments.

• Worked within FDA and DEA guidelines.

Quotient Sciences, Boothwyn, PA

Oct 2017 – Jun 2019

Senior Quality Assurance Specialist

• Perform data/document reviews, investigate/resolve non- conformances, and maintain change control systems.

• Ensure company adherence to Good Manufacturing Practices (GMPs), Good Documentation Practices, applicable regulatory standards, and internal procedures and practices.

• Validate products and equipment, follow IQ, OQ, and PQ standards, and calibrate equipment.

• Produce R&D batches to improve the product quality and perform stability studies for to see the change control effectiveness.

• Assessed and remediated open, closed and past due deviation investigations, product complaints, change controls and CAPAs for accuracy and thoroughness

• Developed, implemented and enhanced Quality Systems processes to meet clinical and commercial regulatory requirements

• Work with other QA functional areas to ensure the deviations, Trackwise, CAPA’s, incidents, atypical, out of spec, variants, etc. reports are reviewed and approved as appropriate.

• In-house auditing, external auditing, and hosting the client auditing, as well as responding to audit comments.

• Worked within FDA and DEA guidelines.

AAA Pharmaceuticals, Lumberton,

NJ May 2000 – Oct 2017

Senior Quality Assurance Supervisor

• Assure the quality of raw materials, packaging materials, and labels.

• Issue batch records; Approve the raw materials, compounding, mixing, compression, and packaging of products.

• Managed all the packaging lines (bottle line, blister line, carton line); In charge of reviewing and approving all packaged products awaiting distribution

• Review batch records and final release of shipments; Train all employees to ensure compliance with cGMP and in-house SOP

• Evaluated, reviewed and approved laboratory and stability program procedures including stability protocols and data

• Write and review SOP, follow up and investigate complaints of any QA related issues; Work with other QA functional areas to ensure the change control, deviations, CAPA’s, incidents, atypical, etc. reports are reviewed and approved as appropriate.

• In-house auditing, third-party auditing, and hosting the client auditing, as well as responding to audit comments.

• Worked within FDA and DEA guidelines.

• Weigh, check and dispense proper raw materials for the development and validation batches.

• Conduct batch record review of GMP Batches; Followed up on the batch record corrections to ensure compliance with cGMP.

• Supervise and approve all stages from raw material receiving up to finished product labeling and consolidation for shipping.

• Communicate with vendors and suppliers for relevant issues associated with raw materials.

• Store and quarantine retained sampler in the proper storage room and the update file; Assure all packaging component clearances.

• Conduct QA in process inspection, audit and line clearance during manufacturing; Worked within FDA and DEA guidelines.

Contact this candidate