FM team-Jr. Manager

Designation : Jr. Manager

Job Location : Bangalore

Reporting to :

Job Grade : Jr. Manager

The Company

Syngene International Ltd. (BSE : 539268 NSE : SYNGENE ISIN : INE398R01022) is an integrated research development and manufacturing solutions company serving the global pharmaceutical biotechnology nutrition animal health consumer goods and specialty chemical sectors. Syngenes 4500 scientists offer both the skills and capacity to deliver great science robust data management and IP security and quality manufacturing at speed to improve time-to-market and lower the cost of innovation. With a combination of 1.9 Mn sq ft of specialist discovery development and manufacturing facilities as well as dedicated research facilities for Amgen Baxter Bristol-Myers Squibb and Herbalife Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.

Specific Responsibilities :

• Drive the client and regulatory audits and address the audit finding related to BMP5 Facility.
• Facilitate and monitor the performance of regular facility walkthroughs and internal quality audits for biologics operations to ensure adherence to the implemented systems and compliance with regulatory requirements including data integrity assessment.
• Responsibility for establishment and implementation of a robust cleaning sanitization & sterilization process.
• Monitoring of equipment which are related to Facility Management and responsible for adherence to current SOP and safety requirements.
• Lead and monitor management of garments and general consumables as per BMP5 facility requirements.
• Review the SOPs protocols study reports procedures in BMP5 operations.
• Lead and monitor timely tracking of Operational and Compliance Metrics for manufacturing Operations and management reporting.
• Facilitate and monitor the implementation of the approved CAPA for the Biologics Operations in Facility Management section.
• Training to the facility team to established procedures and ensure compliance by all personnel.
• Leading the team in effective manner.
• Leading the commissioning and qualification & requalification of all equipments which are related to facility management.
• Support for timely reporting of deviations appropriate investigations to identify the root cause or most probable root cause and proposal & implementation of appropriate CAPA to prevent reoccurrence.
• Review of Facility management and kill system related records and documents.
• Perform the GEMBA and safety walks for production area and other common area of BMP5 facility.
• Support for appropriate manufacturing investigations for OOS and results and customer complaint to identify the root cause or most probable root cause and proposal & implementation of appropriate CAPA to prevent reoccurrence.
• Support for risk management for biologics operations (Facility Department) which covers the following elements and ensured proposal and implementation of appropriate risk mitigation actions (CAPA).
• Quality and Compliance Risks
• Operational Risks
• Data Integrity Risks
• Facilitate and monitor timely review and approval of GMP Documentation for BMP5 Facility Management related major equipments.
• Standard Operating Procedures (EOP IOP and SOP).
• Protocols and Reports
• Any other GMP relevant documentation.
• Leading of BMP5 facility related activities by adhering to Syngenes safety and GMP practices.

Education

Masters degree / bachelors degree in pharmacy Masters degree in Pharmaceutical Sciences.

Industry Experience

Minimum 6-8 years of relevant practical experience in Facility management / Pharma industry.

Other competencies required for the role

Safety and DI Responsibilities :

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 addition Syngene will provide reasonable accommodations for qualified individuals with disabilities.

Pls visit us athttps : / / know more about us and what we do.

Required Experience :

Manager

Key Skills

Computer Hardware,Fund Management,Attorney At Law,Jni,Analytics

Employment Type : Full Time

Experience : years

Vacancy : 1