Trackwise
Vikas Maurya
Pharmaceutical Quality Assurance
Ahmedabad,GJ (India)
Summary
Professional with over 13 years of Quality assurance experience in the Pharmaceutical industry. Having responsibility for plant quality systems, Problem solving and detail oriented. Have worked in a warning environment and fully understand the importance of compliance. Excellent interpersonal and communication skills. Result-driven, skilled leader focused on achieving success and increased productivity through improvement in operations, quality and safety.
Overview
2
2
Languages
2
2
Certifications
2
2
years of post-secondary education
13
13
years of professional experience
Work History
Senior Quality Assurance Associate
Baxter Pharmaceutical India
Ahmedabad, Gujrat
09.2018 - Current
- Management of QMS Compliance for unit - II of Baxter Ahmedabad. (Deviations, CAPA, Change Control and Laboratory Investigations) and achieved targeted KPIs through improvements in Technical writings, development of RFT Culture.
- Coordinated site investigations, documented issues and escalated to executive teams as needed.
- Provide weekly updates to higher management (Tier 3 & Tier 4), keep check on progress and working closely with cross functional SMEs for implementation of improvement actions.
- Collaborated with stakeholders to gather requirements and develop scope.
- Supported exchange of feedback and communication between management and associates.
- Developed junior team members and cultivated collaborative culture.
- Demonstrated knowledge of company mission and goals and mentored team in reaching objectives aligned with company core values.
- Coordinated weekly meetings for internal and external groups, including teleconferences and videoconferences, interacting with all levels of management.
Team Leader
Mylan Laboratories India (Known as Viatris)
Bangalore, Karnataka
08.2016 - 08.2018
- Management of Supplier Quality : Raw Materials, External Service Providers, Packaging and Consumables.
- Execution of external audits (Supplier audits) in defined plan "Frequency - 03 audits per month".
- Preparation, release of audit reports, Follow-up and tracking on progress of compliance report to ensure smooth, systematic closure of audit report with in timeline.
- Preparation, review to establish Quality technical agreements between Mylan and Suppliers/Contract manufacturers/Mylan affiliates sites.
- Built strong relationships with Service Providers/customers through positive attitude and attentive response.
- Initiated timely response to emails, Calls and written correspondence.
Compliance Officer
Reckitt Benckiser India
Mysore , Karnataka
04.2015 - 08.2016
- Evaluation and Monitoring of HPR (High Product Risk) and MQS (Minimum Quality Standards) for Mysore facilities as per Global policies of RB and to take Quality Standards beyond current and expected regulatory expectations. Achieved 93% Score in MQS for Liquid Facility and got appreciation from Top Management.
- Handling of QMS Compliance (Change Control, Deviations, Market Complaints and Recall Management, Internal Audits for Liquid and Tablet Facility.
- Supported exchange of feedback and communication between management and associates.
- Approached each problem with fresh mind and analytical strategies to quickly resolve concerns.
Executive Quality Assurance
Fresenius Kabi Oncology Ltd.
Baddi , Himachal Pradesh
04.2012 - 04.2015
- Quality Management System (Change Management, Risk Management) Deviations and CAPA system). Established timely closure of QMS elements.
- Compliance (Internal Audits), Frequency -01 audit per month.
- Preparation, release of audit reports, Tracking of progress on compliance report to ensure smooth, systematic closure of audit report with in timeline.
- Inspection Management (Regulatory Audits and Internal Global Audits). No Major observation from Regulatory agencies.
- Teachable/open for Learning new system's and guidance.
Executive Quality Assurance
Micro Labs Limited
Baddi, Himachal Pradesh
03.2010 - 04.2012
- Management of Shop Floor (Manufacturing and Packaging Process for OSD Formulations). Established Online process for Inprocess check and Achieved 100% compliance towards online monitoring of Inprocess activities.
- Responsible for Equipment Qualifications and Process Validation. Successfully perform qualification of Software, New Manufacturing facility for oral solid dosage form.
- Handling of Market complaints, Perform investigations, to identify root cause and to established corrective actions.
- Executed mock recalls to have evaluation of real Recall.
- Review of documents (Quality Management System).
Management Staff Member
Cipla Ltd.
Baddi , Himachal Pradesh
06.2008 - 03.2010
- Handling of Change management Process. Monitoring of change control for execution, effectiveness and increased timely closure of change controls in compliant way. Established timeline of 30 days for closure of changes related to procedures.
- Coordinated weekly meetings for Change controls among Cross functional groups, interacting with all levels of management.
- Preparation of Mater Documents Like : MBMR, MBPR, Protocols and SOPs.
Education
Master of Pharmacy -
P.E.S College of Pharmacy
Bangalore, Karnataka, India 06.2006 - 06.2008
Skills
Quality Management System
Software
Metric Stream
Tantra soft
Certification
Post Graduate Diploma in Pharmaceutical regulatory Affairs from Jamia Hamdard University New Delhi.
Interests
Travelling
Books
Timeline
Senior Quality Assurance Associate
Baxter Pharmaceutical India
09.2018 - Current
Team Leader
Mylan Laboratories India (Known as Viatris)
08.2016 - 08.2018
Compliance Officer
Reckitt Benckiser India
04.2015 - 08.2016
Executive Quality Assurance
Fresenius Kabi Oncology Ltd.
04.2012 - 04.2015
Post Graduate Diploma in Pharmaceutical regulatory Affairs from Jamia Hamdard University New Delhi.
09-2010
Executive Quality Assurance
Micro Labs Limited
03.2010 - 04.2012
Management Staff Member
Cipla Ltd.
06.2008 - 03.2010
Professional diploma in Clinical research from catalyst clinical services, New Delhi.
08-2007
Master of Pharmacy -
P.E.S College of Pharmacy
06.2006 - 06.2008
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