Padmalaya Nayak
Bangalore
Summary
Results-driven pharmaceutical professional with 12 years of comprehensive experience in the industry. To seek a challenging position in pharmaceutical industry which gives me an opportunity to utilizes my skills for Versatile Business Operations .Specialist with background in optimizing operational processes and implementing effective business solutions. Skilled in project management, strategic planning, and process improvement, consistently delivering results that drive efficiency and reduce costs. Strong analytical abilities and problem-solving skills contribute to successful project outcomes and positive impacts on overall business performance.
Overview
11
11
years of professional experience
Work History
TEAM LEAD VISUAL INSPECTION
DR REDDYS Laboratories
Hyderabad
01.2025 - Current
- Identified areas for improvement, narrowing focus for decision-makers in making necessary changes.
- Ensured compliance with industry standards and regulations.
- Reviewed completed work to verify consistency, quality, and conformance.
- Visual Inspection Program Development:Lead the design, development, and implementation of visual inspection standards for parenteral products, ensuring compliance with regulatory requirements and industry best practices.
Evaluate and validate visual inspection processes, including both manual and automated inspection methods, to achieve optimal quality outcomes.
Establish risk-based inspection strategies for different types of parenteral products and materials (e.g., vials, syringes).
Harmonize visual inspection control strategies and practices across the internal and external manufacturing network.
Technical Expertise & Process Optimization:Serve as the go-to expert on visual inspection processes, equipment, and quality standards for the parenteral product lines.
Conduct root cause analyses and implement corrective and preventive actions (CAPAs) for quality related events.
Collaborate with cross-functional teams (QA, manufacturing, engineering, TSMS) to identify and implement process improvements that enhance efficiency and reduce inspection errors.
Training & Development:Develop and deliver training programs for quality inspectors, operators, and other relevant staff, focusing on the visual inspection of parenteral products and adherence to GMP requirements.
Mentor junior staff and develop training materials to promote inspection skills and quality awareness within the organization.
Compliance & Documentation:Ensure compliance with FDA and any other global applicable regulatory standards by keeping inspection processes and documentation up-to-date and audit-ready.
Participate in internal and external audits, providing expert insights and support for any inspection-related findings.
Act as subject matter expert for the development and maintenance of internal quality system documents (Global Q standards, Common Q practices,…) and execution documents (validation reports, PoDs…) to support the visual inspection Quality System.
Innovation & Continuous Improvement:Explore and evaluate new technologies and methodologies in visual inspection, including AI, to enhance accuracy and efficiency.
Identify opportunities for process automation, working closely with engineering teams to implement new tools and technologies.
Senior executive
Biocon biologics india limited
Bangalore
07.2020 - 12.2024
- Looking for day to day visual inspection of injectable products target vs actual.
- Handling team for day to day visual inspection activities.
- Looking for compliance and QMS in visual inspection of injectable products.
- Working as a department training coordinator
- Involve in SOPs, protocol preparation and document review.
- Involve in qualification of equipment and area.
- Involve in equipment installation and qualification.
- Qualification and requalification of automatic visual inspection machines for vials,cartridges and PFS.
- Involve in daily planning and meeting the targets on daily basis with CFT team.
- Preparation of monthly outputs in present in power point presentation.
- Involve in daily meetings with cross functional teams and discus daily plans and execution.
- Handling of Track wise for initiation of CAPA, Change control, Deviation etc.
- Tracking and assigning training for team as a department training co-ordinator.
- Involved in qualification of visual inspectors and review of qualification document.
- Preparation of KNAPP kit and qualification kit for visual inspector qualification.
- Currently working on MES implementation project.
Senior officer
Sun pharmaceuticals
Vadodara
12.2018 - 07.2020
- Handling of QMS activities.
- Initiation and investigation of deviation
- Implementation of an correct and effective CAPA.
- Preparation of URS and risk assessments.
- Involve in equipment qualification and requalification.
- Preparation of Draft SOPs and protocols.
- Handling team and worked as line supervisor.
Team member
Dr Reddys laboratory
Vishakhapattanam
10.2016 - 12.2018
- Day to day supervision of visual inspection
- Handling of 20 qualified visual inspector for smooth activity of visual inspection.
- Executing BMR in MES .
- Daily review of Batch manufacturing record and submitting to QA.
- Involved in visual inspector qualification and requalification
- Preparation of monthly output tracker and present in power point presentation in monthly meeting
- Involved in daily planning and meeting the targets in end of the day.
Junior executive
Biocon biologics india limited
Bangalore
12.2013 - 10.2016
- Day to day supervision of visual inspection.
- Daily and taking the batches for inspection.
- Closing of Batch manufacturing record and submitted to QA.
- Qualification and requalification of visual inspection operators.
- Initiation and investigation of deviation related to visual inspection.
- Dispensing of primary packing material from warehouse.
- Worked as a departmental training coordinator.
- Audit exposure, USA FDA, MHRA, TGA, domestic Regulators.
Education
Master in science -
Bangalore university
Bangalore, Karnataka08.2014
Bachelor of science -
Bangalore university
Bangalore, Karnataka06.2012
Skills
- SOFT SKILS
- Microsoft Word
- Microsoft Excel
- Microsoft Power point
- Six Sigma
- Minitab
- SAP
- Track wise
- MES
- DMS
- LMS
- DCMS
- Dochub
- SAP
- Eval
- MES
- Audit exposure: (USFDA, MHRA, EMA, TGA, PMDA Japan, and domestic regulations)
- Certificates:
- NCC A, B, C certificate holder
- Six Sigma yellow belt
- Second prize in KAIZEN implementation
- Platinum award in 5S implementation
Languages
English
First Language
Telugu
Intermediate
B1
Kannada
Beginner
A1
Hindi
Upper Intermediate
B2
Hobbies and Interests
- Reading novels
- Hiking and trekking
- Cricket and volleyball
- Running
- Making friends
Declaration
I hereby declare that the information provided in this resume is true and accurate to the best of my knowledge.
Name:Padmalaya Nayak
- DOB:09/04/1990
- Permanent address:At-Bagada Kasipur,Po:Chhayalsingh,Via:Bonth,Dist - Bhadrak,Odissa,pin-756114
Timeline
TEAM LEAD VISUAL INSPECTION
DR REDDYS Laboratories
01.2025 - Current
Senior executive
Biocon biologics india limited
07.2020 - 12.2024
Senior officer
Sun pharmaceuticals
12.2018 - 07.2020
Team member
Dr Reddys laboratory
10.2016 - 12.2018
Junior executive
Biocon biologics india limited
12.2013 - 10.2016
Master in science -
Bangalore university
Bachelor of science -
Bangalore university
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