Formulation Lead

JOB DESCRIPTION

Designation: Deputy Manger

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:

Managing Injectable and OSD facility, Quality Assurance Department (Having exposure in Liquid & lyophilized Injectable and OSD Products).

Job Description:

1. Review and approval of equipment s/systems/facility specific SOPs, Protocols & Reports.
2. Review and approval of protocols & reports for process validation, cleaning validation, computer system validation and other qualification related documents as per requirement.
3. Review and approval of facility related drawings/layouts (pressure differential, AHU zoning, area classification, equipment layouts).
4. Review and approval of calibrations of the instruments related procedures, planner.
5. Review and approval of Preventive maintenance of the equipment.
6. Review and approval of QMS documents (Change control, Deviations, Investigation etc.)
7. Review and approval of QC/Micro specifications.
8. Preparation of Site master file, Validation Master plan and product quality review (PQR)

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. In-process Product Quality Monitoring.
5. Review of Master, Executed Batch Manufacturing Records, Packing and Dispatch records.

Educational Qualification:

B. pharm/M. Pharm/M. Sc. with minimum 10 -15 years of working experience in Liquid & lyophilized Injectable and OSD Products.

Technical/functional Skills:

Candidates should have adequate knowledge and experience and handle the customer and regulatory audits.

Experience: 10 to 15 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 be able to work in a 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 accommodation for qualified individuals with disabilities.