Quality Control Assistant Supervisor - KELIX BIO MALTA - Birzebbugia, Malta
(2025-07)
- Supervise daily QC laboratory operations ensuring GMP compliance and adherence to quality standards
- Oversee analytical testing activities including raw materials, in-process samples, and finished products.
- Manage deviation investigations, CAPA implementation, and root cause analysis for laboratory non-conformances
- Review and approval of documentation in DoT compliance software.
- Investigate any non-conformities in laboratory and responsible for timely closure with concrete Root cause analysis and CAPA implementation.
- Coordinate with QA, Production, and Regulatory teams to ensure seamless quality operations
- Participate in interviewing, selection, and onboarding of QC analyst candidates with manager.
- Monthly Track and report team performance metrics against defined KPIs and SLAs.
- Leading team, attend cross functional meetings and discussions and deputation manager role in absence.
- Reviewing Analytical raw data and release samples within the define timeline and Train and mentor QC analysts on analytical techniques, SOPs, and GMP requirements. Support regulatory inspections and internal audits with documentation and technical expertise.
Quality Control Team Leader - AMINO CHEMICALS LTD - Marsa, Malta
(2023-07 - 2025-07)
Additional duties performed in Quality Assurance department along with above responsibilities.
- Led team of QC analysts in performing analytical testing for pharmaceutical products and raw materials
- Managed laboratory workflow, resource allocation, and prioritization of testing activities
- Conducted method validations, instrument qualifications, and stability studies and Provide training to junior QC analysts for Good Laboratory Practices.
- Performed deviation investigations, trend analysis, and initiated corrective actions.
- Collaborated with Quality Assurance on batch disposition and regulatory submissions and Ensure compliance with GMP, GDP during internal and external audits.
- Prepare and Review of Annual Product Quality Review (APQR) and Review Supplier Qualification report.
- Review Batch Production Record (BPR) and Review Production log books.
- Review Analytical Finished Products documents and Prepare and Review of Finished Products Certificate of Analysis (COA).
QC Analyst - APL SWIFT SERVICES (MALTA) LIMITED - Birzebbugia, Malta
(2023-03 - 2023-07)
- Perform analysis of different dosage forms like Tablets, Capsules, Injectable and Syrups on different analytical Instruments like Pharma tablet tester, KF titrator, UV FT-IR, HPLC, Friability tester, Disintegration tester etc.
- Assign samples in LIMS software and print out worksheet for the analysis from LIMS and Review and process chromatograms in Empower 3 software.
- Review and calculate analytical results in LIMS software and Perform Analysis of different products on various analytical Instruments with 99.0% accuracy.
- Participated in OOS investigations and documented findings in accordance with SOPs.
- Supported continuous improvement initiatives to enhance laboratory efficiency.
Deputy Manager Quality Control - APICORE PHARMACEUTICALS PVT LTD - Vadodara, India
(2018-12 - 2023-02)
- Independently Lead QMS activity like OOS, Deviation, Change control etc.
- Responsible for Investigation any QMS non-conformance like incident, OOS, Deviation and construct CAPA.
- Review and approval of QMS documents like Change control, Validation Protocol and Reports, Annual Product Quality Report, Deviation Master control. Also training management in Master control software. Successfully reduce Invalid OOS by 90% with concrete CAPA implementation and regular trainings.
- Successfully faced USFDA audit and QP audit during my tenure and directly interacted with the auditor from the QC.
- Interaction with cross functional team for the conclusion of Investigation of Non conformance.
- Arrange teams meeting with the customers for providing analytical support for their failure Investigation.
Senior Executive Quality Control - LUPIN LIMITED - Vadodara, India
(2010-10 - 2018-12)
- Reviewed Analytical raw-data for Finished products, In-process, Intermediate, Raw-material and AMV with 99% accuracy.
- Prior to that perform analysis of raw-material, Inprocess, Intermediate and Finished product samples.
- Lead Raw-material section with team of 10-persons with the SLA more than 95% for the 12-months.
- Lead Six sigma quality Improvement project (e-GB) at site to improve sigma level of Quality attributes.
- Perform all Activities in SAP like sampling, Usage decision, COA and Label printing, Control sample management, release etc.
