Executive - QC

TerumoBCT; Thiruvananthapuram; On-site; INR 600,000 - 900,000; Full time

Job summary

Terumo Blood and Cell Technologies seeks an Associate – Executive QC to ensure on-time testing, analysis and documentation in line with regulatory guidelines. The role spans chemical, functional and incoming inspections, with involvement in calibration, data integrity and reporting across projects.

Experience in pharmaceutical testing, GMP knowledge and ability to manage multiple priorities are essential. Shift flexibility and collaboration with global teams are expected.

Qualifications

• Bachelor’s degree in pharmacy or Master’s degree in pharmacy (Pharmaceutical Analysis/Pharmaceutics/Pharmaceutical Chemistry) or Master’s degree in chemistry.
• 3 to 5 years of experience in Testing laboratory of pharmaceutical industry.
• Knowledge on instrumental analysis and microbiological testing.
• Familiarity with Pharmacopoeial requirements (USP/IP/EP).
• Data integrity and capability to handle multiple priorities.

Responsibilities

• Complete testing as part of Chemical, Functional and incoming inspection.
• Support Global Quality projects and gap assessments.
• Analyze and inspect raw materials, in-process testing and finished product; ensure data recorded per guidelines.
• Report, trend, and present results; calibrate glassware and instruments.

Skills

Instrumental analysis

Microbiological testing

Pharmacopoeial testing

Data integrity

Analytical methods

Equipment qualification

USFDA/EuGMP knowledge

Education

Pharmacy or Chemistry degree

Tools

Ion chromatography

HPLC

UV

GC

FTIR

Job description

Job Description:

At Terumo Blood and Cell Technologies, our 8,000+ global associates are proud to come to work each day, knowing that what we do impacts the lives of patients around the world.

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient's life every second of every day and are committed to continuing to increase the number of patients we serve.

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Consider joining our team and unlock your potential.

Title of Associate - Executive QC

JOB SUMMARY:

Ontime completion of testing, analysis, and documentation with respect to regulatory guidelines.

REPORTING:

Reports to Assistant Manager QC.

ESSENTIAL DUTIES:

Administration/Internal Communications:

• Responsible for completing testing as part of Chemical, Functional and incoming inspection.
• Responsible for providing support to Global Quality projects.
• Responsible for providing support to complete gap assessments.

Other duties and responsibilities

• Responsible for Analysis and inspection of raw materials, accessory items and finished product.
• Responsible for In-process Testing and water testing.
• Responsible for making sure that data is accurately recorded in accordance with guidelines.
• Responsible for reporting, trending, and presenting results.
• Responsible for Calibration of Glassware and Instruments.
• Responsible for ensuring products are complying to the established regulatory guidelines with respect to product compliance.
• Responsible for ensuring GLP and cGDP requirements are in place.
• Responsible for supporting WCM, Lean, Six Sigma projects, root cause analysis, Productivity projects.
• Responsible for empowering people by giving required training
• Responsible for qualification of analytical instruments and QC equipment
• Responsible for New product evaluation and stability studies.
• Responsible for Monthly trending of test results.
• Responsible for subcontractor training and audits.

MINIMUM QUALIFICATION REQUIREMENTS:

Education:

• Bachelor’s degree in pharmacy or master’s degree in pharmacy (Pharmaceutical Analysis/Pharmaceutics/Pharmaceutical Chemistry) or Master’s degree in chemistry

Experience:

• 3 to 5 years of experience in Testing laboratory of pharmaceutical industry.
• Technical Experience/knowledge and Skills required in below.

• Knowledge on instrumental analysis (Ion chromatography/HPLC/UV/GC/FTIR/ etc)
• Knowledge on Microbiological testing (Environmental monitoring, Sterility test, Microbial identification, Microbial Enumeration, Bacterial Endotoxin Testing etc).
• Knowledge on performing test as per Pharmacopoeial requirements (USP/IP/EP)
• Data Integrity
• Knowledge on different type of chemical analysis
• Abletounderstandandidentifykeyobjectivesacrossthebusiness.
• Abletodealwithmultipleissues,tasksandprioritiesconcurrently.
• Knowledge about Analytical/Microbiological test and Equipment Qualification
• Preferable to have Knowledge about USFDA/EuGMP requirements.

Additional Requirements

• Capable to work in all shifts including All three shifts (Night Shift on requirement).
• Have strong communication skills complimented with right technical skills to drive meaningful discussions.

Terumo BCTs Core competencies

• Integrity – Responsible for life and health, should have that sense of mission.
• Quality – Responsible for Safety and quality at all stages of manufacturing should have a Gemba perspective.
• Creativity- Capable for taking up challenges for the future and work with passion.

PHYSICAL & TRAVEL REQUIREMENTS:

• Need to travel across INDIA based on the requirement.

Terumo Penpol is part of Terumo Group and is headquartered in Thiruvananthapuram, Kerala. As India’s largest blood bag manufacturer, we provide a comprehensiverange of blood collection, storage and processing solutions for blood centers, hospitals and therapeutic apheresis centers in India and abroad. Our high-quality products touch the lives of patients in over 80 countries across the world.

True to our mission of contributing to society through healthcare, our award-winning Corporate Social Responsibility initiatives reinforce our organizational values and culture. Firmly rooted in core values collectively termed as the 'Associate Spirit', our work culture fosters an environment conducive to growth and continuous learning. People are our greatest asset, and we place as much importance in their professional development as in the research and development of our products.