Ketan Trivedi

Email: ad4klv@r.postjobfree.com #732-***-****

Quality Assurance & Packaging Lead

Summary:

Over 9 years of combined experience in QualityAssurance and Packaging in regulated life science industries.

Thorough knowledge of GMP, cGMP Standards, 21 CFR, Part 210, Part 211 Compliance, a strong base in packaging line clearance, batch record reviews and in processsampling.

Influential leader in implementing AQL driven sampling methodology.

Supported hosting, fact-findings and response for various regulatory agency and internal audit.

Involved in developing and implementation of critical procedures with respect to Quality Assurance Initiatives, cGMP warehousing, compliantmanufacturing.

Excellent skills in technical writing for and procedural development for commercial packaging of solid dosage, and aseptic product packaging.

Experience in Biotechnology Healthcare, Pharmaceutical and a strong knowledge of compliances in these industries.

Dynamic person with drive and perseverance, innovative, creative and enjoys challenges. Positive attitude and desire to complete tasks.

Good communication skills along with analytical and problem solving skills.

Multitasking, decision making, independently & Team Player as well with management ability.

Ability to help on CAPA for finding the root cause of any incorrect incidents.

SKILLS:

Strong Decision making ready to meet business challenges with positive outlook.

Quality Assurance floor activities. Maintaining quality assurance standard.

Training Junior Team members with management & supervision skill.

Inventory check and verified counts, warehouse material check.

Documents controlled, review batch records, Log Book Verifications, Paper works.

EXPERIENCE:

Sun Pharmaceutical Industries LTD

NJ

Packaging Lead – Quality Assurance (Sep 2015–SEP 2023)

• Served as a principal quality assurance representative and worked with various Packaging personnel to facilitate quality assurance activities associated with processes.

• Coordinated work with broader QA and Packaging team to conduct packaging line clearance.

• Established and performed in-process sampling based on AQL sampling scheme.

• Reviewed/Audited all Packaging Batch Record documentation - Reconciliations, Calibrations Records, LogbooksIn-Process data.

• Reviewed batch records; cross-check against specifications for accuracy, completeness, and to identified any potential issues

• Upon identification of variances, notified proper department Supervisors

• Maintained/controlled hardcopy files for all effective master batch records.

• Created/revised/maintained PDF versions of all master batch records.

• Prepared/issued production records and associated batch documentation and maintained department-specific metrics for management review.

• Implemented and maintained activities for development batch record review, SOP review, temperature excursions, dating extensions, complaints handling, document archival, in compliance with cGMP, SOPs, GDP, and in accordance with corporate, regulatory, and manufacturing timeline expectations.

• Assisted in compiling data for finding route cause and CAPA.

• Mentored and trained junior quality assurance staff.

• Planned and established technical communications, document flow, testing requirements, and resources necessary to support quality reviews of Packaging records in timely fashion.

Aurolife Pharma

Dayton, NJ

Senior Packaging Operator (Sep 2013– Sep 2015)

• Examined pharmaceutical packaging machinery at the beginning of each shift to ensure good working order.

• Performed preventative and general maintenance on machines and components on a regular basis.

• Started packaging machinery and test run it to ensure its working order.

• Took pharmaceutical packaging orders from supervisor and ensure that they are followed accurately during the entirety of the packaging process.

• Regulated components and dials to control the speed and type of packaging.

• Observed machinery to ensure conformance to quality and set standards.

• Maintained and upgraded knowledge of pharmaceutical packaging processes to ensure quality work.

• Reported/escalated any problems or deviations in packaging procedures on an immediate basis to ensure that incorrect packaging does not take place

• Prepared associated packaging documentation according to provided SOPs

• Assisted in reconciling in-process and finished drug packaging and batch recording procedures

EDUCTAION:

oBachelor of Arts in English Literature, Gujarat University, India

oDiploma in Electrical Engineering, Gujarat University, India

oPG Diploma in Computer Application, Gujarat University, India

Contact this candidate