Assistant Manager

Job Description

Designation: Associate manager/Chem Dev OperationsJob Location: BangaloreDepartment: Chemical Development - OperationsAbout SyngeneIncorporated 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 PurposeThe purpose of this role is to Facilitate smooth and quality operations of all the equipment and instrument at PRD laboratories and 100% compliance on regulatory/ quality/training requirement associated with the same and document pertaining to audit and CAPA compliance.Key Responsibilities:

• Evaluate the current Chem Dev equipment and instruments and its asset status
• Up- to-date on the all the operational documents and procedures directly or indirectly related lab instruments or equipment
• Track and monitor Capacity, Resource utilization as a diagnostic control
• Track monitor the employee training and compliance of the same
• Regular monitoring of preventive maintenance of instrument and break down assistance
• Regulatory and quality compliance- Document up keeping, archival and data integrity
• Regular quality and compliance audits both Internal & external and CAPA closure
• Close monitoring of Monitor infra structure project progress against the plan and resolve critical bottle necks and Capex forecast
• Active involvement in implementation of regulatory and EHS compliance programs and best practices and Capex forecast
• Awareness about ISO, FDA and other global quality standards in terms of equipment and instrument
• Internal and external audit compliance
• Dashboard publication and on time escalations
• Bringing up best practice in the interest of org Benefits
• Cross functional coordination and customer focus
• Good in quality documentation and communication

Educational Qualification:

• Degree: Bachelors or Master s degree in life sciences or allied fields (B.Sc/B.Tech/M.Sc/M.Tech/B.Pharm/M.Pharm);
• Certifications (if any): anything related to regulatory and quality compliance

Technical/functional Skills:

• Experience in handling PRD lab instrument and equipment
• Experience in working Chemical labs and its compliance
• Excellent communication (Oral and written) and people management skills
• Good Knowledge on regulatory and quality compliance in terms of equipment/ instrument
• Knowledge on API and requirement
• Knowledge/hands on experience on the various application software for quality and compliance, like EDMS, LIMS, Trackwise etc
• Knowledge/ Hands on experience in training compliance and software
• Knowledge on FDA, ISO, PMDI and other European regulatory bodies
• Knowledge about 21 CFR part-11 compliance and its requirement

Experience:

• 9-12 years post qualificationBehavioral Skills:

• Strong commitment to exceptional customer experience, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team and cross-functional environment.
• Excellent 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.
• Exceptional influencing and leadership skills
• Programming experience is a plus to automate tools whenever appropriate

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.,

Keyskills :
external auditquality compliancemiscustomer experiencepeople managementquality standardstatapplication softwaresalesconsumer goodsbankingdata integrityquality operationsaccounts