Senior Manager - Quality Assurance - Chemical Development

Job Description

Designation: Manager Job Location: Bangalore Department: Quality Assurance Chemical Development 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:
• To handle FDA inspection and explain quality system along with all quality related documents directly.
• To handle review of batch manufacturing record, qualification and validation documents.
• To implement of all SOPs and if any deviation, is reported and investigated adequately in timely manner.
• To ensure adequate closure of all QMS within timeline.
• To ensure Market compliant are closed adequately in timely manner.
Key responsibilities:
• Responsible for any time readiness of manufacturing site.
• Able to handle FDA inspection and explain quality system along with all quality related documents directly.
• Responsible for review of batch manufacturing record, qualification and validation documents.
• Responsible for implementation of all SOPs and if any deviation, is reported and investigated adequately in timely manner.
• Adequate closure of all QMS within timeline. Investigation are adequate with respect to root cause, CAPA and impact assessment.
• Market compliant are closed adequately in timely manner.
• Batches are released in time and without any discrepancies. No complaint from client.
• To ensure Manufacturing is carried out as per GMP requirements. Any discrepancies are reported and closed in timely manner without impacting quality of batch. No audit observation.
• To provide training to IPQA team on GEMBA walk to identify observations with respect to GMP and SOP vs practice to ensure any time audit readiness.
• Adequate planning of planned internal/external audit, hosting of audit to ensure no Major and Critical observations. No repeat observations in the internal audit.
• Ensure process and cleaning validation are carried out as per protocol.
• Involve in all major investigation and ensure adequate investigation are carried out.
• To present quality overview and KPI compliance to management in governance forum.
• Track all MOM items of QGF, BU meeting and present in next meeting.
• Ensure training of all QA person are done in timely manner. 100% compliance.
• Identify non-value added work and duplicate work for effective usage of work force.
• Ensure Quality score card and KPI are tracked and met.
• Ensure correct and adequate data are provided to quality head in timely manner for senior management quality reviews.
• Ensure Shift management are done in line with manufacturing requirements.
• Any gap in the quality system, practices and facility is identified and system put in place.
• Possess the knowledge and exposure to environment, health, and safety (EHS) practices
• Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety
• Ensure environment, health, and safety (EHS) measures are imparted via training and adhered within the team.
Educational Qualification: Minimum M.Sc. in chemistry Technical/functional Skills: Candidate should have exposure in API manufacturing and drug development. Experience: 10- 15 years Behavioral Skills:
• Excellence in Communication
• Conflict Resolution
• Work-life balance
• Time-Management
• Self-improvement
• Stress Management
• Patience
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. ,

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