Formulation Manufacturing- Senior Executive Job in Syngene International

Designation: Formulation Manufacturing- Senior Executive

Job Location: Bangalore

Department: Pharmaceutical 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

Responsible for supervision of solid oral dosage Manufacturing activities as per production plan, safety, documentation and compliance for facility.

Key Responsibilities:

Documentation Management for Preparation, Review & Approval of the SOP's, EOPs, IOPs. Area monitoring etc both manually and in electronic document management system (EDMS) as a author and coordinator.

Document management for Preparation, Review, approval of URS, DQ, IQ, OQ and, PQ of equipments/ instruments etc both manually and in electronic document management system (EDMS) as a author and coordinator.

Support for FAT, evaluation of equipment risk assessment, Assist in protocol preparation for Decommissioning of existing equipments and commissioning from at new facility.

Support for entire plant Area validations, Qualification to meet projected timelines.

Support in building, Implementation and following of cGMP requirements at all stages to meet compliance w.r.t. USFDA, EU, MHRA standards.

Support in facility planning to achieve weekly, monthly targets, capacity utilization, monitor and up keeping for smooth functioning of production activities, clinical batches manufacturing/commercial batches manufacturing.

Monitoring and maintenance of equipments logbooks

Purified water plant management and to ensure smooth functioning of water system.

Training to Technicians on New equipments and instruments during installation.

Support and co-ordination with various cross functional teams to meet project timelines.

Raising indent for new instruments /equipments/ new accessories for day to day functioning of formulation development centre.

Work allocation to technicians in formulation development centre.

To monitor, control and handling of tooling and change parts for all equipments in Development lab and OSD pilot plant.

To ensure implementation of EHS policy.

Support in preparation of various client visits, regulatory and QP audits.

Management of QMS documentation like change controls, incidents, deviations investigations, CAPA etc both manually and in electronic Quality management sy stem (EQMS).

Training of SOP, EOP and IOP to all employee related to formulation production.

Support in linen management (cleaning, storage and inventory of garments).

Ensures that the new employee has indicated their signature in specimen signature logbook on or prior to sign off the job description.

Identifies the training needs in consultation with Department Head for employees initially and whenever there is change in job roles and responsibilities of employees.

Prepares a training matrix as per the defined job roles for the new entrant.

Ensures that the training needs of all employees in the department are completed.

Archiving of training records of respective departmental employees.

Ensures training records of resigned employees are stamped as per the procedure.

Uploading of content in LMS and mapping of cross-functional procedures to users.

Identifying and maintaining the training records of all the approved service providers.

Filing of any evaluated questionnaires in respective training records.

Ensures training files are reviewed and certified by the concerned Quality Assurance after training completion.

Tracking of completion of training for the identified employees in LMS

Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety

Attend training on environment, health, and safety (EHS) measures imparted company

Educational Qualification:

Bachelors degree in Pharma

Technical/functional Skills:

Experience in solid oral dosage manufacturing facility. Granulation, compression, coating and packaging

Experience in parenteral or semi solid manufacturing facility would be added advantage.

Experience:

3-6 years post qualification

Behavioural Skills:

Should have the capability to work in a team and ability to handle demonstrate a good team spirit.

While possessing a good ability to follow instruction should also demonstrate innovative in his/her approach, good communication skills.

Should be proactive while working on allotted responsibility.

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.