Job Description

JOB DESCRIPTION

Designation: Senior Manager

Job Location: Bangalore

Department: Formulation Development

About Syngene

Syngene ( ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.

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

Mandatory expectation for all roles as per Syngene safety guidelines

• Overall adherence to safe practices and procedures of oneself and the teams aligned
• Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company\'s integrity & quality standards
• Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
• Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
• Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self
• Compliance to Syngene\' s quality standards at all times
• Hold self and their teams accountable for the achievement of safety goals
• Govern and Review safety metrics from time to time

Role Purpose:

• To be responsible for leading manufacturing science technology transfer activities for oral solid dosage forms (tablets and capsules)

Key Responsibilities:

• To be the technical point of contact for internal and external stakeholders for technology transfer into GMP manufacturing.
• To liaise with the R&D team or Customer for direct transfer of external processes to ensure processes for GMP manufacture are robust, scalable, and suitable for the GMP specific equipment and to ensure gap analyses of equipment, facilities, and processes.
• Ensures that all tech transfers into operations are controlled and implemented within GMP regulatory guidelines.
• To oversee and support the technical support for process-related investigations, process improvements, product impact assessments, change control assessments, CAPA assessments, RM/PM qualification, etc.
• Lead and support for compilation of dossiers to regulatory/ customers.
• Lead process validation activities and continued process verification, Annual Product quality Review for all manufacturing processes/products for global regulated market.
• Lead and support for implementation of post approval changes such as API variations, alternate equipment validations.
• To coach manufacturing team members and shop floor technicians on delivering of the products with high quality standards and right first-time manufacturing.
• Shall have good communication skills and should be able to drive projects in R&D\'s work plan are transferred to Pilot scale, Pivotal scale and commercial scale based on requirement.
• Work with Project leads to undertake specific transfer activity as appropriate to the project.
• Should have faced regulatory inspection like USFDA, EU GMP, MHRA etc.
• Responsible for ensuring compliance of QMS activities like change control, Deviation, Investigations, OOS, OOT, validation protocols and CAPA.
• Preparation/ review of Risk assessment, process validation protocols, scale up protocols and reports, batch records as and when required.
• To ensure that best practices for GMP/Safety are implemented at manufacturing sites and follow statutory & regulatory expectations.
• Overview of inventory of RM/PM/FP etc.

Educational Qualification: M Pharma

Experience: Minimum 12 -15 years\' experience in manufacturing, science, and Technology Transfer in oral solids (Tablets and Capsules)

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.

Syngene International