Senior Executive QC

Role & responsibilities

• Responsible for completing testing as part of Microbiological and incoming inspection. Responsible for Document Review and Approval
• Responsible for providing support to Global Quality projects.
• Responsible for providing support to complete gap assessments.
• Responsible for Analysis and inspection of raw materials, accessory items and finished product. Responsible for Document and Test Report Reviews and Approval
• Responsible for In-process Testing and water testing.
• Responsible for Microbiological testing (Sterility/BET/Microbial Enumeration/Clean room monitoring)
• 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.

Preferred candidate profile

Experience:

• Not less than 7 years of experience in Testing laboratory of pharmaceutical industry.
• Technical Experience/knowledge and Skills required as below.

1. Knowledge on instrumental analysis (Vitek, LPC etc)
2. Knowledge on Microbiological testing (Environmental monitoring, Sterility test, Microbial identification, Microbial Enumeration, Bacterial Endotoxin Testing etc).
3. Knowledge on performing test as per Pharmacopoeial requirements (USP/IP/EP)
4. Data Integrity o Knowledge on different type of chemical analysis o Able to understand and identify key objectives across the business.
5. Able to deal with multiple issues, tasks and priorities concurrently.
6. Knowledge about Analytical/Microbiological test and Equipment Qualification
7. 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