Anand babu A
Manager production and QMS
Bangalore
Summary
Experienced Production Manager with 15+ years in pharmaceutical manufacturing, specializing in Quality Management Systems (QMS), production operations, team leadership, process validation, and continuous improvement. Proven track record in handling global and local standards, regulatory compliance, technology transfer, and cross-functional collaboration. Recognized for driving efficiency, delivering on project milestones, and maintaining the highest quality standards.
Overview
19
19
years of professional experience
8
8
Certifications
Work History
Manager Production and QMS
AstraZeneca
12.2015 - Current
- Handling of e-QMS (change control, deviations, CAPA's and market complaints) using Track wise, Veeva Vault.
- Handling of qualifications, re-qualifications & validations (process and cleaning validations).
- Preparation and review Authorized of all documents including validation protocols/reports of all products, areas, equipments and systems in accordance with cGMP and regulatory requirements.
- Responsible for review of packing material artwork and approval as per regulatory requirement.
- Supporting to Regulatory affairs team for filing regulatory approvals.
- Handling of change control, market complaints and Product recalls.
- Involved in technology transfer from global to regional site
- Actively involved in planning and launching of new products.
- Actively involved in CSV activities in production Equipments.
- Planning of Volumes on machines to achieve weekly and monthly targets as per market requirements.
- Co-ordination with supply chain to arrange raw materials and packing materials as per production schedule.
- Management of contract manufacturing site and supply chain to deliver the products within agreed timelines.
- Monitoring and trouble shooting in production activity.
- Handling of manufacturing and packing activity with different products and strengths in shifts
- Handling of manpower and allotment of manpower to operate all the machines.
- Preparation of documentation of manufacturing and packing process in SAP.
- Ensuring correct packing material reached to packing lines after any change in packing materials.
- Support Stamping/Stickering process for Institutional business
- Review Batch records for compliance and support batch release
- Interact with cross site QP’s of China, UK, Sweden, and Mt Vernon-US Sites for approval of Blanket approval for Rework batches and comply to local regulatory requirement
- Involved in value stream mapping process for rework -institutional Business
Production officer
Cipla Ltd.
06.2010 - 12.2015
- Management of contract manufacturing site and supply chain to deliver the products within agreed timelines.
- Monitoring and trouble shooting in production activity.
- Performing online in-process analysis
Production Officer
Cipla Ltd.
03.2006 - 07.2007
- Preparation of documentation of manufacturing and packing process in SAP.
- Management of contract manufacturing site and supply chain to deliver the products within agreed timelines.
- Preparation and Implementation of Standard operating procedure.
- Planning and Execution of production activity as per the Export requirements.
- Supported for equipment Qualification and re qualifications.
- Handling of manufacturing and packing activity with different products and strengths in shifts.
Education
Master of Pharmacy - Pharmaceutics
Jagan's college of Pharmacy
Nellore, Andhra Pradesh01.2012
B Pharmacy - undefined
Sri Lakshmi Narasimha college of pharmacy
Chittoor, Andhra Pradesh01.2010
Diploma in Pharmacy - undefined
Sri Pulla Reddy Govt. Poly technic
Kurnool, Andhra Pradesh01.2005
Skills
- Experience in production management with global and local standards and preparation and review of quality assessment
- Management of contract manufacturing site and supply chain to deliver the products within agreed timelines
- Expertise in applying management tools/ approaches to reporting business within the business unit
- Responsible to maintain quality output with regulatory expectation
- Strong exposure in e- QMS, Veeva Vault and track wise
- Qualification & validation of solid oral
- Supporting for artwork review and labelling as per regulatory requirement
- Strong exposure in Manufacturing and packing controls in solid oral formulations
- Good knowledge on process with modern professional quality competence
- Proficient in compliance of data to prepare and report through detail analysis
Certification
Implement new electronic system for management of QMS (Veeva Vault.)
Timeline
Manager Production and QMS
AstraZeneca
12.2015 - Current
Production officer
Cipla Ltd.
06.2010 - 12.2015
Production Officer
Cipla Ltd.
03.2006 - 07.2007
B Pharmacy - undefined
Sri Lakshmi Narasimha college of pharmacy
Diploma in Pharmacy - undefined
Sri Pulla Reddy Govt. Poly technic
Master of Pharmacy - Pharmaceutics
Jagan's college of Pharmacy
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