QA Operations Manager
Apply NowCompany: Kavis Pharma LLC
Location: Sugar Land, TX 77479
Description:
POSITION PURPOSE
A brief summary of the purpose this position must fulfill.
Manage the Quality Assurance (QA) Operations department. Ensures operations activities are maintained in a state of control and in compliance with internal SOP's and current Good Manufacturing Practices.
Perform job functions in accordance with all applicable Standard Operating Procedures (SOP), federal and state laws, Occupational Safety and Health Administration (OSHA) guidelines, health authority regulations, and departmental processes.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this position successfully, an individual must satisfactorily perform each essential duty. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
Manage QA Operations functions. Activities include raw material, excipient, and component sampling.
Quality oversight of manufacturing and packaging operations.
Manage the review and final release of raw materials, components, bulks, finished product, stability, and clinical supplies by assuring accuracy and lot integrity through the enforcement of established control procedures.
Prepare department SOP's and ensure cGMP requirements.
Be the SME for all quality related activities in the SAP system.
Assist with investigations including impact assessments and data gathering.
Report and ensure that site metrics are met every month.
Manage the development of personnel. Responsible for performance and set goals and objectives with team members. Participate in production meetings to provide and obtain information in support of the production schedule and site goals.
Actively pursue the identification, development, implementation of initiatives related to continuous improvement and/or operational excellence. Interact, participate and complete investigations and CAPA activities.
Perform other duties as assigned.
QUALIFICATIONS
The qualifications listed below are representative of the minimum knowledge, skill, and/or ability required.
KNOWLEDGE
Must possess working knowledge of Quality Systems and validation processes for the Pharmaceutical Industry, cGMP, ICH and Pharmacopoeia (USP, EP) requirements. Also, must have knowledge of interpretation of established standard operating procedures and operational excellence strategies required.
SKILLS AND ABILITIES
Must possess strong verbal, leadership and communication skills, and well - developed ability to constructively work across functional areas. Ability to multitask and evaluate priorities. Experience with various software, such as MS Word, Excel, Access and PowerPoint, and knowledge of familiarity with SAP and TrackWise.
SUPERVISION
Position functions autonomously. Position directly supervises employees. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
EDUCATION/EXPERIENCE
Minimum of a Bachelor's degree (or equivalent) and 5 years of experience, 5 years or more experience in the pharmaceutical industry with a background in validation and/or quality engineering preferred. However, a combination of experience and/or education will be taken into consideration.
LICENSES/CERTIFICATIONS
None
LANGUAGE SKILLS
Ability to read and interpret comprehensive and intricate research documents. Ability to write scientific reports and technical correspondence. Ability to work with executives and communicate abstract concepts. Ability to present to a high level of the organization and groups outside of the organization.
MATHEMATICAL SKILLS
Ability to solve equations, apply technical mathematical concepts, and perform complex computations.
REASONING ABILITY
Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis. Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.
Typically sitting at a desk or table. Intermittently sitting, standing, walking or stooping. Periodic travel is required. May be required to stand; walk; stoop; bend; kneel; and climb steps; May require use of hands and arms. Medium lifting requirements.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential duties of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.
Office and pharmaceutical manufacturing environment.
A brief summary of the purpose this position must fulfill.
Manage the Quality Assurance (QA) Operations department. Ensures operations activities are maintained in a state of control and in compliance with internal SOP's and current Good Manufacturing Practices.
Perform job functions in accordance with all applicable Standard Operating Procedures (SOP), federal and state laws, Occupational Safety and Health Administration (OSHA) guidelines, health authority regulations, and departmental processes.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this position successfully, an individual must satisfactorily perform each essential duty. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
QUALIFICATIONS
The qualifications listed below are representative of the minimum knowledge, skill, and/or ability required.
KNOWLEDGE
Must possess working knowledge of Quality Systems and validation processes for the Pharmaceutical Industry, cGMP, ICH and Pharmacopoeia (USP, EP) requirements. Also, must have knowledge of interpretation of established standard operating procedures and operational excellence strategies required.
SKILLS AND ABILITIES
Must possess strong verbal, leadership and communication skills, and well - developed ability to constructively work across functional areas. Ability to multitask and evaluate priorities. Experience with various software, such as MS Word, Excel, Access and PowerPoint, and knowledge of familiarity with SAP and TrackWise.
SUPERVISION
Position functions autonomously. Position directly supervises employees. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
EDUCATION/EXPERIENCE
Minimum of a Bachelor's degree (or equivalent) and 5 years of experience, 5 years or more experience in the pharmaceutical industry with a background in validation and/or quality engineering preferred. However, a combination of experience and/or education will be taken into consideration.
LICENSES/CERTIFICATIONS
None
LANGUAGE SKILLS
Ability to read and interpret comprehensive and intricate research documents. Ability to write scientific reports and technical correspondence. Ability to work with executives and communicate abstract concepts. Ability to present to a high level of the organization and groups outside of the organization.
MATHEMATICAL SKILLS
Ability to solve equations, apply technical mathematical concepts, and perform complex computations.
REASONING ABILITY
Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis. Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.
Typically sitting at a desk or table. Intermittently sitting, standing, walking or stooping. Periodic travel is required. May be required to stand; walk; stoop; bend; kneel; and climb steps; May require use of hands and arms. Medium lifting requirements.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential duties of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.
Office and pharmaceutical manufacturing environment.