Quality Compliance Associate Job in Granules India Limited

Job Summary

The QA Associate ensures compliance with cGMP and internal policies, procedures and specifications. This position is responsible for performing inspections, batch record review, and quality system functions in accordance with cGMP and related company SOP s, state, federal and local laws as applicable. This person should be knowledgeable of cGMP requirements, FDA regulations and ICH guidelines. The persons is responsible for the execution and oversight of the cleaning and process validation activities as well.

Principle Accountabilities

JOB DESCRIPTION& RESPONSIBILITIES

• Ensure that products meet approved company policies, process and procedures.
• Perform In-process Quality assurance job functions and support to the manufacturing operations
• Perform and support maintenance and closure activities of documents such as reports, change controls, protocol review.
• Drive the timely implementation and closure of change controls while ensuring compliance to applicable quality standards and change control procedures.
• Author and review standard operating procedures.
• Prepare and execute cleaning validation/verification documentsalong with calculation of the acceptance criteria for all equipment available at the site.
• Perform the release of finished product batches packaged in house and from contract packagers.
• Help in the completion and organization of vendor qualification documentation
• Preforms all labeling activities from the creations to the management of changes.
• Ensure labeling requirements are met as per company SOP s, which includes incoming inspection and release.
• Knowledge in the serialization of pharmaceutical products.
• Perform and support maintenance and closure activities of documents such as reports, protocols exceptions/deviations, CAPAs, change controls and complaints.
• Any other activity as assigned by the Supervisor

Management Responsibility Reports to

Quality Compliance Associate Director

Internal/External Contacts

N/A

Knowledge & Skills

• Demonstrate knowledge in process and cleaning validation/qualification.
• Knowledge of Quality Management Systems, including FDA compliance standards, cGMP regulations/guidelines.
• Knowledge of USFDA regulations/guidance s and ICH guidance s.
• Knowledge of Change Control/Deviation management and CAPA identification/implementation.
• Proficient in Microsoft Word, Excel, Power Point.
• Knowledge of labeling requirements for the pharmaceutical industry.
• Ability to analyze data/information and to assess and resolve complex issues, as required.
• Ability to work and communicate with cross-functional teams.
• Ability to manage multiple priorities and re-prioritize tasks, as required.
• Flexible and able to adapt to company growth and evolving responsibilities.
• Strong attention to detail and excellent organization.
• Excellent oral and written communication skills.

Experience & Education

• Bachelor s degree in a Natural Sciences (i.e. Biology, Chemistry), Pharmacy, or Engineering.
• At least one (1) to three (3) years experience in a quality assurance role in a cGMP-regulated environment.

Physical Requirements/Working Environment

• While performing the duties of this job, the employee is regularly required to, stand, sit, talk, hear, and use hands and fingers to operate a computer and telephone keyboard.
• Light to moderate lifting up to 10-15 lbs. is required.

Travel

Up to 5 % travel may be necessary.