Jaya Akkeneni
Summary
Results-driven professional with extensive experience in Quality Assurance and Quality Control, specializing in risk assessment and compliance activities. Proven track record in managing change controls using Trackwise and Veeva modules, ensuring operational effectiveness and adherence to quality standards. Skilled in stakeholder management, collaborating with cross-functional teams to address quality-related issues and enhance product safety. Proficient in various computerized systems, including JDE and SAP, with a solid understanding of GMP, GCP, and ISO standards.
Overview
14
14
years of professional experience
Work History
LOC Quality Business partner
Haleon Australia Pty Ltd (Legacy GSK Consumer Healthcare division)
03.2020 - Current
- Maintain a high level of GMS knowledge and awareness of changes within the commercial and supply chain environment to seek opportunities and support business needs.
- Support the LOC Quality Lead to ensure that all internal procedures and systems in use in the LOC are compliant to Haleon and local regulatory requirements.
- Third Party Warehouse Management – engage with Logistics to identify third parties that have an impact on product quality for LSP’s DHL & HCL. Ensure regular monthly meetings are in place and KPI’s measured for our LSP’s.
- Third party repacking site – Quality representative, ensuring third party suppliers are approved and that contracted Good Manufacturing Practices (GMP) activities are following local regulatory requirements, quality agreement, & Haleon GMS.
- Reviewing & Approving Packaging work order &repacking request forms for repacking third party.
- Involved in briefing/procurement discussions, provide quality input during process of qualifying new third party facilities (turnkey/fill, transfer of Voltaren sku’s from Taiwan).
- Manage & provide QA support for Contract agreement, service level agreement, Draft Quality agreement between Haleon & external third part contract sites.
- Change Control – Perform day to day work to support the local change control process with the aim of ensuring all planned major changes are effectively and compliantly managed. Perform day to day work by routinely reviewing progress of changes and close out when completed.
- Risk Management – Perform activities to support the risk management process to ensure effective management, timely reporting, review and escalation of quality risks to EMA management.
- Support and coordination for external, internal, and supplier audits through the CAPA process.
- Audit – perform day to day work to support the local process that is in place for Level 1 (management monitoring) and Level 2 (internal business monitoring) audits through the QA audit plan.
- Complaints – perform day to day work to support an effective complaints management process.
- Import permits – day to day work to support shipments that have on going quality of imported products in line with GMS and local regulatory requirements.
- Review and approval of ITS (Technical Terms of Supply) and Quality agreements for approval through liaison with internal stakeholders and manufacturers to ensure compliance to local registered technical details.
- Review and approve Distribution Risk Assessments as required.
- Assisting CTP group to ensure licenses are maintained and support audit questionnaire.
- Supporting third party audits for third party repacking site & LSP’s.
- Review & monitor KPI documents and follow up of CAPA related to audit and to the ongoing management of repacking activity for third party for Haleon.
- Review CAPA plan and effectiveness review.
- Monitoring of repeat deviations, repeated deviations and complaints trend and liaising CAPA if where required.
- Providing QA support to review and approve master dossier ur process and approvals for LSP.
- Understanding supply chain needs and assisting to release batches to avoid OOS situations.
- View support to staff of business stakeholders on and when required to support new project, technical transfer etc.
- Inbound product disposition for products received in QA status. Resolve and manage quality related issues, incidents and deviations as per procedure.
- Support business to effectively manage e-commerce, new route to markets, warehouse & distributor changes, digital and medical devices, new products, launches and to ensure all quality requirements are met.
- Work with internal stakeholders to raise a change control for product to be repacked through a Repacking Request Form. Ensure the right level of approval is obtained for each request.
- Supporting Quality Regulatory Intelligence and Quality Alerts – perform day to day work to assess new issues and regulations and put robust action plans in place. Engage with relevant stakeholders to implement action plans and track completion. Provide regular update to LOC Quality Lead and Quality Council.
- Support the resolution of quality issues and incidents.
- Identify adverse trends and escalate to LOC Quality lead.
Quality Assurance Specialist
Pfizer Australia - Australia
01.2017 - 03.2020
- Release of products received from both Pfizer affiliates including Consumer and animal pharma products and approved third parties. In a released for supply state, as well as restricted product use for their intended purpose. All relevant systems and processes are in control to the quality, safety and efficacy of the finished product are in accordance with the code of GMP, Corporate and Regulatory guidelines.
- Review of batch manufacturing records of Pfizer product as per the relevant Marketing Authorization detail, Reviews Certificate of Analysis, COC and any other relevant information of fully finished products.
- Batch Release for Biological Vaccines and assigning TGA Approval for Cold Chain Products.
- Working closely with Regulatory take notes regarding stability submissions and review of Vaccine Release request form prior to seeking approval from TGA for Nimenrix, Prevenar.
- Review and approve Rework document, manufacturing, packaging and rework document for packaging / rework documentation.
- Develop and prepare QAS and Product Release Documents as appropriate.
- Performing gap analysis reviews for SOP’s and finished product specifications documentation.
- Act as SME to support Quality System Change Control activities. Execute, review and ensure any required change controls are managed and closed within Pfizer’s GMS.
- Assist Documentation Change Control department to validate existing and new processes / systems.
- Conducting internal and external supplier audits.
- Utilising the principles of Right First Time and Risk Management coordinate and manage deviations (QAR and CAPA) in accordance with Pfizer Quality Standards (PQS) such that the causes of problems related to product quality are investigated and initiate appropriate actions, implement continuous improvement actions to prevent the occurrence.
- Develop, review and prepare internal documents e.g. Standard Operating Procedures, Forms etc as appropriate. Create and review SCG documents, Ensure the PQAR report are completed in adherence to PCR Module Lists. Review & Approval of Periodic Product Reviews with Pfizer Affiliates Product Lead.
- Assist in the execution of GMP training of personnel when requested.
- Managing Returned Goods and liaise with distribution warehouse carrier (DHL) and Trade Compliance on the return goods Process Improvement.
- Participate with Right First-Time teams for waivers and introduce new processes.
- Carry out and assist in Quality Risk Management (QRM) for changes and deviations, as necessary.
- Manage product stability program.
- Review / Approval of Annual Product Reviews and submit to TGA.
- Review and approve deviations, Non-conformance raised by LSP providers (DHL).
- Track audit commitments; actions/occurrences.
- Coordinate quality agreements.
- Lead Quality Review meetings.
- Liaise with manufacturing the e. provide required Quality information to Pricing & Tenders Department as required.
- Apply Quality Risk Assessment as necessary.
- Ensure Compliance with the Quality Management policies, in accordance with Pfizer Quality Standards (PQS).
- Ensure compliance with government regulations in relation to quality e.g. Australian Code of GMP and the Therapeutic Goods Act 1989.
Specification Developer
Unilever Australia - Australia
10.2015 - 12.2016
- Contribute to the development of Specification plans by providing the Specification information for resource plans.
- Determine room network required to get the right input into the specification content. This is both internally (Unilever) & externally; R&D design & deploy technologist (SEA & ANZ), Master Data management (MDM) ; Material & 3rd Party Planners, Procurement; External Material (Pack) Suppliers; External 3rd Party manufacturers/converters etc.
- Develop and lead specification management process involving stakeholders (internal/external/formal) to develop specifications.
- Develop allocated codes to meet specification plans by sourcing and providing team with required design inputs to comply with timings.
- Ensure availability of global specifications for ANZ region within ANZ R&D systems. Localise the global specifications in the regional database as required. Localise the required labels with Global team to modify global specifications as required.
- Source and develop specification information from internal and external networks to provide individual specification.
- Complete detailed specifications to meet specification plans to agreed data quality standards using pre-Guides/procedures.
- Specification Status Management – Responsible for the management of the status of specification types during their lifetime e.g. submit specifications for approval, change the status of specifications that have been approved to Current, and any specifications that are no longer in use in any DUs to Historic. This is to be executed to agreed timings.
- Ensure supplier sign-off of specifications to liaise with supply management.
- Responsible for right of specification to liaise issues preventing sign-off.
- Ensure the project lead/key leads shutoff to own work against plans as agreed with the leads (e.g. frequency and format).
- Ensure timely and effective communication & resolution of issues affecting the delivery of the specification portfolio in assigned categories to the spec lead/project lead.
- Ensure the specification codes are up to date and secure records of all specification activity in line with business information standards.
QA Associate
Nestle Pty Ltd - Blacktown, Australia
01.2013 - 09.2015
- Manage day quality activities including line walks, product release, GMP audits and investigation to ensure products are and enjoyed by all.
- Develop new product inspection criteria for raw materials and finished products.
- Training and coaching of operators and team leaders to drive the ownership and meet specification limit.
- Manage repeat deviation trend.
- Write and approve Deviations, Investigations and SOP’s
- Participate in failure analysis and corrective action investigations
- Investigate product inspection criteria (PIC) deviation
- Identify quality performance, trends and corrective actions
- Review records and documents for accuracy, completeness, legibility and compliance with specifications
- Keeping quality documentation up to date
- Assist in Batch reviews and product release.
- Release and reject of raw materials and finished products.
- Conducting line audits in manufacturing process.
- Maintaining good relationships with different areas of QA, manufacturing and warehouse to release the products on timely manner.
- Investigate and respond to customer complaints. Prepare customer complaints reports (monthly and weekly).
- Initiate non-conformance procedures where required and take necessary actions to close NCR’s.
- Participate in taste panels and prepare taste panel reports.
- Manage calibration schedule.
Validation Analyst
GlaxoSmithKline (GSK) - Ermington, Australia
09.2012 - 12.2012
- Product development, process development and process validation.
- Responsible for Method Development of product by Assay, Related Substances, Content uniformity, Uniformity of Dosage units, disintegration and Dissolution.
- Preparing samples and analysing Purity and Assay of the components by HPLC (Empower software) and Wet Chemistry techniques.
- Setting and testing of HPLC (Waters) Instrument.
- Analysing related substances by HPLC and TLC.
- Preparing samples and analysing chemically or physically by HPLC and UV vis spectrophotometer.
- Reviewing Chromatograms and compiling results to scale.
- Responsible for Preparing SOP’s
- Responsible for writing SOP’s and Method development summary report.
- Prepare and maintain accurate and complete technical documentation.
- Documentation in accordance with GLP, GMP and company requirements.
- Responsible for writing up draft Specification Results.
- Maintenance of Records
- Ability to work on cross-functional projects
- Calibration of instruments and troubleshooting according to Internal Schedule
- General Housekeeping Duties
QC Chemist
Nestle Pty Ltd - Blacktown, Australia
12.2011 - 04.2012
- QC testing of raw materials, finished products in accordance with GMP and GCP practice
- Full testing of Raw Materials According to Company Technical Direction, BP and USP companies
- Physical and chemical testing for raw materials.
- Setting of HPLC and GC Systems for Analysis.
- Preparing samples and analysing Purity of the components by HPLC and GC (Chem Station).
- Analysing raw materials by wet chemistry techniques (TLC, PH, Titration, KF for water and moisture content, Limit tests, LOD, Ash content, Conductivity, Assays and Related substances.
- Testing & Buffer solutions.
- Assist in Batch reviews and product release.
- Release and reject of raw materials and finished products.
- Conducting line audits in manufacturing process.
- Maintaining good relationships with different areas of QA, manufacturing and warehouse to release the products on timely manner.
- Documentation in accordance with GLP, GMP and company requirements.
- Responsible for writing up draft Specification Results.
- Assist in Investigating Out-of-Specification results according to QD’s and helping in appropriate action taken.
- Interpretation of results and report writing.
- Assist in Housekeeping duties and housekeeping audits weekly
- Calibration and troubleshooting of instrumentation, where required.
Education
Bachelor of Pharmacy - pharmaceutical analysis, Organic Chemistry, biotechnology, microbiology, preoperative pharmacy, pharmacy practice, Pharmacology, Clinical Pharmacy, synthetic drugs, inorganic chemistry and physical chemistry
Sri C.R. Reddy College of pharmaceutical sciences affiliated to Andhra University
Buv, APSkills
- Quality assurance and compliance
- Transportation oversight
- Attention to detail
- Performance improvement
- Problem-solving
- Change control
- Risk assessment
- Third party oversight
Timeline
LOC Quality Business partner
Haleon Australia Pty Ltd (Legacy GSK Consumer Healthcare division)
03.2020 - Current
Quality Assurance Specialist
Pfizer Australia - Australia
01.2017 - 03.2020
Specification Developer
Unilever Australia - Australia
10.2015 - 12.2016
QA Associate
Nestle Pty Ltd - Blacktown, Australia
01.2013 - 09.2015
Validation Analyst
GlaxoSmithKline (GSK) - Ermington, Australia
09.2012 - 12.2012
QC Chemist
Nestle Pty Ltd - Blacktown, Australia
12.2011 - 04.2012
Bachelor of Pharmacy - pharmaceutical analysis, Organic Chemistry, biotechnology, microbiology, preoperative pharmacy, pharmacy practice, Pharmacology, Clinical Pharmacy, synthetic drugs, inorganic chemistry and physical chemistry
Sri C.R. Reddy College of pharmaceutical sciences affiliated to Andhra University
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