Job as Senior Executive, QA at Thermo Fisher Scientific /B.Pharm, M.pharm, M.Sc

Thermo Fisher Scientific Inc. is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of $13 billion, we have approximately 39,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through three premier brands, Thermo Scientific, Fisher Scientific and Unity™ Lab Services, which offer a unique combination of innovative technologies, convenient purchasing options and a single solution for laboratory operations management. Our products and services help our customers solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity

Post: Senior Executive, QA

Job Description
Business Title: Sr. Executive QA
Reports To: Director, QA
Group/Division: BioPharma Services Division
Business Structure: Fisher Clinical Services
Business Unit: Fisher BioPharma Services (I) Pvt. Ltd.
Career Band: 3
Job Track: Associate

Essential duties & responsibilities:
1) Line Clearance of area and equipment for the job activities performed in packaging area.
2) Performing In process checks during the packaging activity and Blinding activity.
3) Withdrawing the retain samples and customer sample during the packaging activity. Handling of storage and retrieval of retain samples in warehouse and its review.
4) Daily checks in primary and secondary area. Reporting of any deviation incidents in packaging area.
5) Review of filled production orders after completion of packaging activity.
6) Issue and archival of log books /SOPs of area and equipment of packaging area.
7) Verifying of yearly schedule of usage of disinfectant of FCS building.
8) Drafting of SOPs related to QA and QC. Imparting training of revised SOPs. Imparting induction training of QA sops to new joinee. Taking the Master signature of all new joinee after successful training.
9) Performing of microbial monitoring of primary packaging area on monthly basis. Coordinating with Gujarat laboratory for testing reports. Compilation of microbial testing results & preparing the trend report of test results.
10) SOP management of all departmental SOPs.
11) Performing review of validation status of all critical equipments and facilities for the purpose of re-validation.
12) Verifying and review calibration status and preventive maintenance schedule of the equipments and instruments in packaging area.
13)Implementation of CAPA originated for Change Control/Incident/OOC/OOT/Recalls/Investigation and maintenance of respective logs.

Minimum Education: B.Pharm / M.Pharm / MSc

Preferred Experience: 5 to 7 + years in pharmaceutical industry

Skills & Attributes:
Good Documentation skills.
Good Communication skills.
Knowledge of working in GMP environment.
Ability to perform Qualification and Validation activities.
Deviation and Change Control management.
Proficiency in working on computer.

Additional info:
Qualification: B.Pharm / M.Pharm / MSc
Experience: 5-7
Location: Ahmedabad
Job Id: 34202BR
Industry type: Pharma