Batch Release Specialist

Batch Release SpecialistJubilant Cadista Pharmaceuticals, Inc.is located in Yardley PA and is a Jubilant Life Sciences Company, a global healthcare company with a wide range of products and advanced technologies. Our strong product development teams and advanced supply chain has enabled us to build a very strong position in a competitive market.Position SummaryThis position performs work and tasks with the Quality Management Systems and SAP for the functions related to batch records review, document management, and procedure controls, as well as review of specifications and test results and assistance with annual product quality reviews. This list is not all-inclusive.Essential Functions(Essential functions, as defined under the Americans with Disabilities Act, may include the following tasks, knowledge, skills and other characteristics. This list of tasks is illustrative ONLY and is not a comprehensive listing of all functions and tasks performed by positions in this class. It does not imply that all positions within the class perform all of the duties listed, nor does it necessarily list all possible duties that may be assigned.)* Maintain quarantine/release/reject system for materials, components, and drug products. * Review batch records and disposition drug product to the market. * Manage the Document Control process. * Maintain a thorough knowledge of appropriate standard operating procedures (SOPs) and initiate procedure update and improvements, as appropriate. * Initiate and perform CAPAs, Change Controls, Deviations, and OOS/OOT investigations. * Perform Annual Product Quality Reviews. * Serve as a resource to CMO's as needed regarding quality issues. * Support regulatory agency inspections.Experience and Qualifications:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the experience and qualifications required:*

Education * Bachelor's Degree in Science or related technical field. * Five (5) years of experience in lieu of degree.*

Industry Experience Required * Five (5) years of related experience. * Lead experience. * Pharmaceutical and FDA regulated industry experience.Knowledge, Skills and Abilities:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills and abilities required:*

Knowledge * Advanced vocational/specialized knowledge. * Knowledge and interpretation of Good Manufacturing Practices (GMP) and quality systems is required.*

* Ability to identify deficiencies in documents and propose changes. * Ability to provide analysis, diagnosis or production tasks which noticeably impact end results. * Communication Skills * Ability to communicate effectively in both written and verbal form with all levels of employees. * Demonstrates strong interpersonal skills and conflict management, with the ability to influence outcomes. * Ability to effectively communicate with all levels of personnel the objective, expectations, and requirements for the department.*

Computer Skills * Proficient skills level with using Microsoft applications, including Word and Excel. * Proficient with SAP.*

Reasoning Ability * Good subject knowledge and problem-solving skills required. * Ability to search for solutions or new applications in differing situations. * Ability to develop new solutions in ambiguous and complex situations. * Self-Management Skills: * Demonstrates accountability to act independently. Subject to practices/well-defined policy, management reviews results after the fact.Working EnvironmentThe working environment demands of this job are physically and environmentally centered on characteristics and abilities involved in this work. The work environment considers the risks and discomforts in the physical surroundings and the nature of the work assigned to ensure that all safety regulations and techniques required to perform the job are precautions practical to eliminate all risks. * Physical*

Position requires repetitive activity. * Position requires prolonged periods of standing, and sitting. * Position requires minimal travel