QMS incharge

Designation: Deputy manager

Job Location: Bangalore

Department: SU3 EAM

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

Handling of QMS documentations like CC,CAPA and Investigations.

Handling of EDMS documents, Study protocols and qualification protocols.

Key Responsibilities:  

• Responsible for performing the activities related to the Engineering & maintenance at Biologics Unit 03.
• Responsible for GMP compliance and error free operations.
• Follow all EHS requirements at all time s in the workplace ensuring individual and plant safety.
• Ensuring all assigned mandatory trainings related to data, integrity, health and safety measures are completed on time.
• Ensuring compliance to quality systems.
• Develop and contribute to development of procedures, practices and setup that ensures safety operations compliant to company and regulatory norms.
• Compliance to current good manufacturing practices
• Adherence to Standard Operating Procedures and safety requirements.

Educational Qualification:  

• Bachelor of Engineering

Technical/Functional Skills:

• Handling QMS documentation.
• Handling of EDMS documents.
• Ensuring system implementation as per the procedures.
• Ensuring audit compliance .
• Reviewing of documents and approvals.
• Responsible to perform the preventive maintenance as per the Schedule.
• Preparation and execution of equipment qualification (DQ, IQ, and OQ) related documentations.
• Responsible to perform the validation, requalification activities as per the schedule.
• 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 BMP facility during shift and day to day operations.
• Preparation of biologics EAM related SOPs related maintenance.
• Attending the breakdown of equipment’s for BMP.
• 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 the HVAC parameters.
• Responsible for QMS closure (CCF, CAPA and Deviations).
• Responsible to involve client and regulatory audits, address the audit findings.
• Compliance to current good manufacturing practices.
• Adherence to Standard operating procedures and safety requirements.
• Responsible for preparation of quality department protocols related to EAM.
• Support 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.
• Responsible to maintain and closing the complaint slips on time.

Responsible to support for qualifying the vendors coordinating with QA.

Experience:

• 9-12  years in the relevant regulated environment

Behavioral Skills:

• Good communication skill, both verbal and written
• High level of dedication, enthusiasm, motivation, and persuasive ability in a team and cross-functional environment.
• 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.

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.