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PDA Singapore Chapter

Bruce Loxley

President: Bruce Loxley

GSK Vaccines

Overview

The chapter was founded in September 2013 to serve PDA members in Singapore.

The Singapore Chapter welcomes you to participate in the activities of the Chapter established to connect the industry stakeholders in the Singapore region and beyond. The Singapore Chapter intends to organize events that are current "hot" topics in the industry. We open our events to both members and non-members.

Please feel free to add us on our LinkedIn page, contact the Chapter Officers, or e-mail us at [email protected] if you have any questions, comments or suggestions. You may also use our email to register to receive our event newsletters.

If you are a member of PDA but have not applied to be a Singapore member, per requirement from Registry of Societies (ROS), please fill in the attached form and e-mail the signed form to [email protected].

 

Upcoming Chapter Events

PDA Signature Events

 

Officers

President

Bruce Loxley

Bruce Loxley
GSK Vaccines

Bruce performs regional and global auditing of GSK Vaccines and third party provider sites and functions focusing on Asia-Pac. He is responsible for Audit Risk Assessment preparation, Audit Planning, Execution and Reporting (including CAPA agreement) both as Lead and Co-auditor. Bruce has 29 years in the Pharma and Vaccines businesses, variety of roles in Validation and Compliance in both Drug Substance and Drug Product Manufacturing in UK, France and Singapore.

President-Elect

Emily Cheah

Emily Cheah 
Charles River Laboratories

A registered pharmacist, Dr. Emily Cheah is currently the Managing Director of Charles River Laboratories Singapore (Microbial Solutions). Emily oversees strategic technical operations and market development in Singapore, Malaysia and Indonesia; and is involved in implementation of new technology / services at the Singapore site. She also conducts numerous trainings for the Industry. She received her PhD (Pharm. Technology) from the National University of Singapore and is currently pursuing her EMBA.

Secretary

Andiyanto Sutandar

Andiyanto Sutandar
HGP Asia

Dr. Andiyanto Sutandar is a Manager in the NNIT Group Life Sciences Divisions of HGP Asia Pte Ltd, Singapore, and manages PT Halfmann Goetsch Partner, Indonesia, operations. Andi leads HGP’s Manufacturing Science and Technology service unit. He has broad and in-depth experience in qualification and process validation, technology transfer, NPI, risk management, deviation and NC management, supply chain management, manufacturing workflow optimization, and project management in the pharmaceutical industry. Additionally, Andi has expertise in infection control risk management and design and management of high containment facilities for the research of infectious diseases.

Treasurer

Christina Chen

Christina Chen
Commissioning Agents Internationsl (CAI)

Christina is the Director of Operations at CAI (Southeast Asia). She has 18 years of C&Q and cGMP experience in equipment operation and validation of various equipment, manufacturing facilities, cleaning processes and process validation with various clients across Asia. Additionally, Christina has extensive experience in project planning, process design and is experienced with technology transfer from R&D to Bio Manufacturing equipment, and in conducting GMP compliance audits within Asia.

Member-at-Large

Richard Chai

Richard Chai
STERIS Corporation

As a Technical Service Manager with STERIS Corporation based in Singapore, Richard has been providing technical training to customers in topics related to cleaning and bioburden control for cleanrooms, including disinfectant validation, as well as cleaning and cleaning validation for product contact surfaces. He is also a frequent industry speaker at ISPE events in various countries such as Singapore, Malaysia, Thailand, Indonesia, Philippines and India. Also presented in various industry events in China, Korea and Japan.

Prior to joining STERIS, Richard had 13 years of manufacturing and validation experience working in dry powder inhaler plant, biotech sterile fill and finish plant, and medical device and biopharmaceutical facilities. He has in-depth understanding of the requirements of cleaning and disinfection in cleanrooms, as well as best practices in bioburden control and sterilization process. Richard has also worked 3 years as a validation consultant providing validation support to various pharmaceutical customers in the area of equipment validation, cleaning validation for product contact surfaces, disinfectant validation, as well as cleaning procedures for both product and non-product contact surfaces.

Member-at-Large

Shi Ming Chau

Shi Ming Chau
Johnson & Johnson

Shi Ming has over 23 years of experience in pharmaceutical industry. He is director of External Quality for Janssen Supply Chain in Asia Pacific responsible for External manufacturers quality management in Asia Pacific countries like China, Korea, Taiwan and Japan etc. Prior to joining Janssen, Shi Ming is with Scinopharm Taiwan where he was the head of quality management overseeing the quality control, quality assurance and compliance functions for the company’s facilities in Taiwan as well as in China. Prior to Schinopharm Taiwan, Shi Ming spent over 16 years working for Schering-Plough Singapore then Merck (MSD) Singapore in the areas of quality control, quality assurance, technical services for technology transfer and cleaning validation as well as served and technical lead for regional business operation function for third party management in Asia Pacific region.

 

Member-at-Large

Lei Wei Chan

Lei Wei Chan
GSK Vaccines

Li Wei is a microbiologist with experience in cleanroom, utilities, product testing and microbial controls in the pharmaceutical and medical devices industry (sterile & non-sterile manufacturing facilities). He is currently responsible for developing microbial control strategies, developing microbiological test methods, managing environmental monitoring program and managing laboratory compliance to corporate and pharmacopoeial standards. He also supports regulatory inspections e.g. FDA, PMDA, HSA, customer inspections, conduct internal inspections and managing QC audit program. Li Wei received his Bachelor of Science (Biotechnology) from Monash University, and is a certified GSK quality auditor.

Member-at-Large

Katie Parks

Katie Parks
Amgen

Katie joined the Amgen Singapore Manufacturing (ASM) site as the Director of Quality Control in October of 2018. In this role, Katie is responsible for overseeing the laboratories that support the ASM biologics and small molecule manufacturing release and stability testing. She joined Amgen in 2006 and has held various roles in Amgen’s quality control organization, most recently at the Amgen Rhode Island biologics manufacturing site in the USA. She has experience in a broad scope of quality control functions, including raw material and product testing, stability, reference standard creation and implementation, laboratory investigation, corrective/preventative actions, and change control. Katie has over 18 years experience in the biotechnology industry. Prior to joining Amgen, Katie worked at Clinical Data in New Haven, CT, which provided genetic testing services. Katie earned a B.S degree in Cellular and Molecular Biology from Tulane University in New Orleans, LA, USA.

 

Member-at-Large

Priyabrata Pattnaik

Priyabrata Pattnaik
Merck

Dr. Priyabrata Pattnaik is Head of Asia Pacific Biologics Operations of Merck overseeing all aspects of business covering technical operations, capital & human resource planning, site operations, technology transfers, logistics & supply chain, facility engineering, EHS & support services. Providing strategic direction for services business in Asia Pacific with P&L responsibility. Dr. Pattnaik has 20 years in the Life Science sector dealing with vaccines and therapeutics, in variety of local, continental and global roles in R&D, Bioprocessing Applications, Technical Support, Market Strategy, Sales Development & technical operations based out of India and Singapore.

Member-at-Large

Rama Tummala

Rama Tummala
GSK Vaccines

A Master of Science graduate specialized in Pharmaceutical Operations, Rama is currently working with GSK as an audit manager in Global Quality Audit & Compliance division. He has over 28 years of pharmaceutical industry experience and previously worked in CIPLA, The Himalaya Drug Co., and Novartis. His expertise includes biopharm, sterile, non-sterile and consumer products manufacturing, QA, Validations, and greenfield project management in India, USA and Singapore.

Volunteer

Prashanth Kumar Basika

Prashanth Kumar Basika
Tessa Therapeutics

Prashanth holds Master’s Degree in Microbiology and is the QC Systems Manager at Tessa Therapeutics Ltd based in Singapore and responsible for QC Systems, Projects and Laboratory Equipment Qualifications. He has 16 years of experience in Quality Control, Quality Assurance & Validation roles in cGxP (ATMPs, Biologics, Nutritionals, Clinical & Beverage) industries. Prior to Tessa, he worked in various QC, QA, Validation, Quality Engineering Roles at PSC Biotech, CPR Pharma, Lonza Biologics, Genentech/Roche and Wyeth in Singapore. He has in-depth understanding of cGxP Systems which includes but not limited to GMP Facility Design/Cleanrooms, QC Operations, Quality Systems, CSV, Data Integrity, Commissioning and Qualification of FUE.

Volunteer

Kwong Toh Lum

Kwong Toh Lum
West Pharmaceutical Service

Kwong Toh joined West Pharmaceutical Services in 2005 & is now the Regional Marketing Manager for Asia Pacific. Prior to joining West, he has over the years assumed roles in Business Development, Sales, Regulatory Affairs and Country Management in the pharmaceutical, medical device and equipment industries. He holds a Bachelor of Science (Hons) in Microbiology from the National University of Singapore and a Masters of Business (International Marketing) from the Curtin University.

 

Get Involved

We encourage PDA members residing in Singapore, to volunteer with the PDA Singapore Chapter by contacting us at [email protected] or fill the Volunteer Opportunities form online.

 

Photos

PDA Singapore Chapter Data Integrity and CSV Symposium

August 28, 2018

Data Integrity and CSV Symposium
Data Integrity and CSV Symposium
 

PDA Singapore Chapter Inaugural Event

April 1, 2014

PDA Singapore Chapter Inaugural Event
 

Sponsorship

Event Sponsorship supports the Singapore Chapter by organizing quality events.

 

Volunteer with the Chapter

(For PDA Members Only)