Welcome to
Services
Manufacturing Support
Product Identification & Support to Business Development
- Identify new products to be manufactured
- Identify business partners
- Present facility capabilities
Facility Set-Up & Review
- Review manufacturing ergonomics
- Compliance to GMP requirements
Handling of Inspections – Regulatory and Customers
- Develop SMEs
- Modulate audit response
- Technology Transfer support
- Interface Tech Transfer protocol
- Monitoring of Technology Transfer activity
- Process scale-up support and evaluation
- Continued monitoring of process
Troubleshooting Generic Solutions
Review of Specific Manufacturing Issues
- Process Optimization
- Yield Improvement
- Defect Trending
- Process Investigations
Review of Specific Quality Issues
- OOS/OOT Results
- Quality Trends
- Response to Market Complaints
- Product Quality Reviews
Development & Technology Transfer
- Review of Development Reports
- Preparing Technology Transfer Protocols
- Review of Technology Transfer
- Continuous Process Monitoring
GMP Based Systems
Defining Review metrics
- Metrics for quantifying manufacturing and Quality systems
Planning and Implementation
- Creating and maintaining an effective structure
Evaluation and Update
- Periodic reports generation
Investigation & Risk Assessment
- Risk based implementation of Quality system
About Us
The services are managed by professional(s) with over 32 years of experience in Quality Assurance and Quality Control in the Pharma sector with various majors like Pfizer, Ranbaxy, Zydus & Lonza.
Held various leadership and senior quality management positions in Ranbaxy, Zydus Lifesciences and Lonza. Part of the Company leadership team in Zydus and Lonza.
Domain Expertise
- QA/ QC (Quality Unit) operations including conceptualizing, planning and executing various projects for ensuring regulatory compliance.
- Manufacturing operations for:
- Formulations – OSD
- Fermentation
- APIs
- Empty Hard Capsules (Various polymers)
- Multi-function handling and support to Product Development and Technology Transfer.
- Proficient in use of analytical tools for evaluating quality and productivity trends.
- Skilful and effective handling of customer and regulatory agency audits.
- Effective communicator with management skills & strong analytical, problem solving abilities.
- Keen understanding of business commercials.
Professional Engagement
- Currently engaged as consultant in OSD Softgel Pharma and Nutra business.li>
- Director Quality (Capsugel|Lonza) Nov, 2015 to March 2022
- Sr, General Manager CQA Cadila Healthcare) Nov. 2014 to Nov. 2015
- AVP – QA and Compliance (Arch Pharmalabs) Sep. 09 to Nov 2014
- General Manager–Corporate QA Unimark Remedies) Feb. 08 to Aug. 09
- Senior Manager Corporate QA (Ranbaxy Labs Ltd.) Jul ’07 – Jan. ‘08
- Senior Manager Quality Assurance (Plant at RLL) Apr 97 to Jul 07
- Quality Operations Officer (Pfizer India Ltd.) Apr. ‘90 to Mar. ‘97
Notable Milestones
- Trouble shooting and Effective system and process corrections (CAPA)
- Responsible for driving and directing the Quality and Compliance Activities at Site.
- Handling the compliance initiatives with the customers for CRAMS deliverance.
- Successful handling regulatory inspection
- USFDA
- EU-GMP
- TGA
- WHO, Geneva>
Contact Thin Compliance
Address: C-58, South Extn-II, New Delhi, India
Phone: +91-99997 69396
Email: sharad.raizada@thincompliance.com
Business Hours: 9:00 AM to 6:00 PM
Weekends Closed