Headquartered in Salisbury, Maryland, Jubilant Cadista Pharmaceuticals Inc. is a noted, top 10 fastest growing generic pharmaceutical company in the United States. Vertically integrated with the parent company (Jubilant Life Sciences) in India, Cadista applies its local market expertise and technical capabilities to all forms of solid dose products to enhance patient outcomes. Cadista employs approximately 300 employees and generates approximately 100MM in annual revenue. The site is uniquely located on the Eastern Shore within 30 minutes east of beautiful Ocean City, Maryland and the same to the Chesapeake Bay to the west. For more information, visit www.cadista.com.
Position Summary:
To provide leadership in the compliance efforts for the pharmaceutical production process and demonstrate deep and broad knowledge of the quality functions as well as the ability/desire to add value in a highly entrepreneurial & empowered setting. In addition to possessing hands-on knowledge concerning the daily activities of the Quality Assurance department, this employee will manage all Quality Assurance systems.
Essential Functions:
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 or Advanced Degree in Pharmacy, Chemistry, Biology or related scientific field.
Industry Experience Required:
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:
Communication Skills:
Excellent verbal and written communication skills are mandatory. Attention to detail in communication is essential. Ability to carefully proofread reports and obtain corrections of any flaws is required.
Computer Skills:
Basic computer skills (MS Office) are essential.
Reasoning Ability:
Must possess logical reasoning ability to be able to successfully evaluate investigation reports.
Leadership:
A proven ability to demonstrate deep and broad knowledge of the quality functions listed above as well as the ability/desire to motivate fellow employees to improve quality and compliance.
Working Environment:
The working environment demands of this job are physically and environmentally center around 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:
We offer an excellent benefit package, 401k and relocation assistance!
Salary commensurate with experience.
It is the policy of Jubilant Cadista Pharmaceuticals, Inc. (herein “Cadista”) to provide equal employment opportunity to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sexual orientation, gender identity and/or expression, marital status, status as a disabled veteran and/or veteran of the Vietnam Era or any other characteristic protected by federal, state or local law. In addition, Cadista will provide reasonable accommodations for otherwise qualified disabled individuals.
Position Summary:
To provide leadership in the compliance efforts for the pharmaceutical production process and demonstrate deep and broad knowledge of the quality functions as well as the ability/desire to add value in a highly entrepreneurial & empowered setting. In addition to possessing hands-on knowledge concerning the daily activities of the Quality Assurance department, this employee will manage all Quality Assurance systems.
Essential Functions:
- Lead the GMP compliance efforts for pharmaceutical production process related to solid oral dosage forms.
- Develop and conduct compliance related training as needed.
- Coordinate QA functions for the assigned area of responsibility and act as key compliance liaison with Manufacturing, Packaging, Warehouse and other functional departments.
- Recognize the need for investigations due to deviations from written procedures, review investigations into non-conformance incidents/deviations, and recommend disposition of the affected product/component.
- Prepare and ensure timely completion of deviation/investigation reports.
- Prepare trend reports related to in-process monitoring, deviation reports, investigation reports and CAPAs. Follow-up with functional department for timely completion of corrective and preventive actions recommended.
- Perform annual and random audits of production, warehouse, maintenance, and analytical laboratory, etc.
- Recommend continuous improvement plans based on observation of process, vendors, data, etc. to management.
- Maintain a thorough knowledge of appropriate standard operating procedures.
- Recommend/initiate SOP updates and improvements as appropriate.
- Monitor and audit manufacturing for cGMP compliance and serve as a key resource to production regarding quality and compliance issues.
- Conduct product complaint and adverse event investigations and prepare responses as needed.
- Review/approve change control documentation.
- Assist in hosting outside audits, i.e. FDA audits.
- Perform personnel evaluations as needed.
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 or Advanced Degree in Pharmacy, Chemistry, Biology or related scientific field.
Industry Experience Required:
- Five to ten years of Quality Assurance or Quality Control experience in the pharmaceutical manufacturing environment is mandatory.
- Three to five years of experience at a Manager level is preferred.
- Excellent combination of knowledge and application of cGMP standards is expected.
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:
Communication Skills:
Excellent verbal and written communication skills are mandatory. Attention to detail in communication is essential. Ability to carefully proofread reports and obtain corrections of any flaws is required.
Computer Skills:
Basic computer skills (MS Office) are essential.
Reasoning Ability:
Must possess logical reasoning ability to be able to successfully evaluate investigation reports.
Leadership:
A proven ability to demonstrate deep and broad knowledge of the quality functions listed above as well as the ability/desire to motivate fellow employees to improve quality and compliance.
Working Environment:
The working environment demands of this job are physically and environmentally center around 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:
- Frequent sitting, talking and/or hearing
- Reaching with hands and arms
- Walking short distances
- Extensive word processing and data entry work on computers will be involved.
- Interaction with other departments including Manufacturing, Quality Control, and Product Development & Technical Services with respect to documentation will be involved.
- Work is regularly performed inside in an office.
- The work area would be an office space generally involving a work desk and a computer.
- Potential exposure to dust, odor, noise, and fumes.
We offer an excellent benefit package, 401k and relocation assistance!
Salary commensurate with experience.
It is the policy of Jubilant Cadista Pharmaceuticals, Inc. (herein “Cadista”) to provide equal employment opportunity to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sexual orientation, gender identity and/or expression, marital status, status as a disabled veteran and/or veteran of the Vietnam Era or any other characteristic protected by federal, state or local law. In addition, Cadista will provide reasonable accommodations for otherwise qualified disabled individuals.