Need now Senior Executive/Junior Manager
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- 3 to 8 Yrs
- Bengaluru
- 11 months ago
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Job Description
Job role: Senior Executive/Junior Manager -Deviation Management and Manufacturing Investigations
Job Location: Bengaluru, India
Reporting to: Manufacturing Operations- Function head
Level - 9/8
About Syngene
Syngene International Ltd ( https://www.syngeneintl.com/ ) is an integrated research, development, and manufacturing organization providing scientific services - from early discovery to commercial supply. We offer services in a wide range of industrial sectors, including pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical companies. Our culture of scientific innovation is driven by the expertise of our highly qualified team of 5,000 employees and is supported by state-of-the-art infrastructure and market-leading technology.
At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and SOPs, in letter and spirit.
Core Purpose of the Role
Objective of this role is to perform Deviation and Out of Specifications Investigations as per global quality standards and regulatory expectations for Biologics Operations.
The candidate must be willing to work as part of the Manufacturing Operations team. This position does not fall under the umbrella of the Quality Assurance function.
Role Accountabilities:
- Timely reporting of deviations and perform appropriate investigations to identify root cause or most probable root cause and proposal & implementation of appropriate CAPA to prevent reoccurrence.
- Perform appropriate manufacturing investigations for OOS results and Customer Complaints to identify root cause or most probable root cause and proposal & implementation of appropriate CAPA to prevent reoccurrence.
- Participate in the audits as SME for OOS investigations and manufacturing investigations.
- Timely tracking of Operational and Compliance Metrics for Manufacturing Operations and management reporting.
- Ensure Risk Management for Biologics Operations covering following elements and ensure proposal and implementation of appropriate risk mitigation actions (CAPA)
- Perform and support timely preparation, review and approval of GMP documentations.
- Conduct and/or support training on SOPs, protocols and On-the-Job activities.
- Timely proposal and implementation of appropriate CAPA for audit findings.
- Participate in regular facility walkthroughs and internal audit for Biologics Operations to ensure adherence to the implemented systems and compliance with regulatory requirements including Data Integrity assessment.
- Support for implementation of Operational Excellence Initiatives for the Operating Unit (OU).
Education
M.Sc/B.Tech in Biotechnology
Relevant experience
3-8 years of relevant work experience in Biotech company
Professional Skills and Capabilities
- Excellent technical writing and presentation skills.
- Hands-on experience on GMP Investigations with use of Root Cause Analysis (RCA) tools will be preferred.
- Excellent communication and conflict management skills.
- Knowledge and experience on the concept of Risk Management (System Level, Component Level and/or other suitable tools)
- Working experience with cross functional teams.
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.
Employement Category:
Employement Type: Full timeIndustry: Pharma / Biotech
Role Category: Sales / BD
Functional Area: Not Applicable
Role/Responsibilies: Need now Senior Executive/Junior Manager
Contact Details:
Company: SygeneLocation(s): Bengaluru
Keyskills: quality standards internal audit technical writing sales mis root cause customer complaints animal health
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