Job Description

Designation: Junior Manager

Job Location: Bangalore

Department: Engineering and maintenance

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: Maintenance and Management of Shift Activity in QC Biologics. To Perform preventive and Break down Maintenance.To provide support to Biologics Qc operations.

Key Responsibilities:

• Responsible for maintaining the facility, equipment in GMP compliance state as a team member of maintenance at Biologics QC.
• Responsible to perform the preventive maintenance activities as per schedule.
• Preparation and execution of equipment qualification (DQ, IQ, OQ) related documentations.
• Responsible to prepare the master list and planners as per the schedule.
• Planning and coordinating with vendor to carryout external AMC and equipment PM.
• Monitoring and maintaining all utilities for QC facility during shift and day to day operations.
• Preparation of biologics EAM related SOPs related to maintenance.
• Attending the breakdowns of equipment\'s for biologics.
• Identifying and maintaining the critical spares.
• Responsible for reconciliation and archival of documents.
• Providing the trainings for service providers and contract engineers.
• Responsible for clean utilities maintenance.
• Daily monitoring of HVAC parameters.
• Responsible for QMS closure. (CCF, CAPA & deviations)
• Responsible to involve in client and regulatory audits, address the audit findings.
• Responsible for preparation of quality department protocols related to EAM.
• Supporting for preparation of General procedures and standard operating procedures of EAM.
• Responsible for maintaining the BU approved layouts.
• Responsible for completing the inhouse modifications/projects.
• Responsible to perform the SAP activities.
• Responsible to maintaining and closing the complaint slips on time.
• Responsible to support for qualifying the vendors coordinating with QA.

Educational Qualification: BE/ B Tech

Knowledge / skills / competencies:

• 1) Shall have exposure of pharmaceutical industries.
• 2) Exposure of Analytical instruments is mandatory.
• 3) Shall have basic knowledge of Electrical system and analytical equipment\'s like HPLC, and high end analytical instruments Etc. other than HVAC and facility maintenance in Biopharmaceutical industries.
• 4) Shall have knowledge of GMP systems.

Experience: 5-10 years

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.

Syngene International