Title:  IPQA Executive

JOB DESCRIPTION

Designation: Senior Executive  

Job Location: Bangalore

Department: Quality Assurance

About Syngene

Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.

Job Purpose:

New Hire in Formulation for OSD facility, Quality Assurance Department

Job Description:

1. Line Clearance during Batch change over and Product Change over.
2. Conducting cGMP inspections across the manufacturing plant and supporting area.
3. Issuance of Batch Numbers, Batch Manufacturing Records, Packing and Dispatch records.
4. Review of Master, Executed Batch Manufacturing Records, Packing and Dispatch records.
5. Preparation and review of standard operating procedures.
6. Review of equipment qualification documents.
7. In process Product Quality Monitoring.
8. Dispatch inspection and Clearance.
9. Monitoring of dispensing and other relevant warehouse activity
10. Inspection of Raw material (RM), packing material (PM) and manufacturing consumables for any damage/discrepancy possible during receipt, storage, dispensing and handling of these materials in Warehouse.
11. Issuance of Format numbers, Log books, Operating Procedures.
12. To ensure implementation and propagation of all EHSS norms so as to create safe working environment.

Key Responsibilities:

1. Preparation, review and revision of QA Procedures.
2. Any other responsibility as assigned by Head QA based on knowledge, Experience and learning.
3. Ensure IPQA activities at shop floor during manufacturing
4. Line Clearance during Batch change over and Product Change over.
5. In process Product Quality Monitoring.
6. Dispatch inspection and Clearance.
7. Review of Master, Executed Batch Manufacturing Records, Packing and Dispatch records.

Educational Qualification:

M. Pharm with minimum 3 -5  years of working experience with OSD facility.

Technical/functional Skills:

Candidate  should have adequate knowledge and experience in IPQA shop floor activities in OSD facility.

Experience: 3 to 4 years

Behavioral Skills:

• Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team.
• Good speaking-listening-writing skills, attention to details, proactive self-starter.
• Ability to work successfully in a dynamic, ambiguous environment.
• Ability to meet tight deadlines and prioritize workloads.
• Ability to develop new ideas and creative solutions.
• Should able to work in team and flexible for working in shifts.
• Should be a focused employee.

Equal Opportunity Employer:

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.