Quality Manager
Quality Manager
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$ 110000 - 140000
1 Vacancy
Job Description
QUALITY MANAGER
General Overview
The quality manager is responsible for the overall quality operations of the plant that involves planning and of robust quality systems and processes meeting our customers expectations as well as the applicable regulatory/health authority requirements.
Key Responsibilities
- Develops deploys and sustains a comprehensive quality assurance program by establishing the appropriate policies procedures and controls that ensures reliable supply of consistent quality products conforming to established standards regulatory requirements and customers expectations.
- Provides expertise and guidance in interpreting governmental regulations agency guidelines and internal policies to assure the state of compliance for the plant at all times.
- Serves as the liaison between the company and the various governmental agencies including FDA.
- Be the Quality point person for all our customers suppliers and regulators.
- Establishes deploys and operationalizes effective Quality Management System (QMS) in line with the international guidelines (viz. ISO 22716 USFDA Part 210 211 etc. to demonstrate compliance to cGMP requirements for all categories of products that we produce/supply.
- Hosts quality inspections by the regulatory agencies/health authorities (FDA) quality audits by the thirdparty accreditation bodies (ISO) and by our customers. Prepares audit responses and drives actions to close the audit/inspection observations with evidence of it being effective and sustainable.
- Be the advocate of cGMP and quality in all operations. Conducts periodic training for all involved in the cGMP activities across functions and levels at the plant.
- Establishes suitable processes and controls for new products and/or processes introduction into plant.
- Creates and drives of Validation Master Plan (covering manufacturing/packing/cleaning processes equipment/utilities qualifications testing methods computer systems etc. for the plant defining clear strategy/approach and frequency that ensures plant operates in validated state to meet the applicable regulatory compliance and achieve customer satisfaction.
- Be the custodian of all GXP documents including Product Formulations Products/Materials Specifications Test Methods Manufacturing Work Instructions Batch Manufacturing/Packing Records and any other documents received from our customers.
- Works directly with Operations to ensure that quality inspections statistical process control analyses and internal audits are conducted as specified to enforce requirements and meet specifications. Responsible for administrating inspection procedures and standards.
- Establishes and ensures that quality control testing and/or inspections are conducted for the incoming raw/packaging materials inprocess/bulk product and finished products in accordance to the relevant specifications. Owns the disposition decision based on conformance to agreed specifications.
- Investigates customer complaints promptly leads quality investigations to identify the rootcause/s and drives systemic resolution of all quality related issues if required through robust CAPA.
- Meets department financial objectives through the development and management of annual budget.
- Identifies department goals and delivers results tied to departmental and plant goals.
- Manages and develops direct reports through goal development addressing performance and identifying training.
- Ensures timely completion of all required departmental and plant safety training. Ensures a safe working environment.
Qualifications
Basic Minimum Requirements
- Meet the legal minimum age requirement.
- Authorized to work in the United States.
- BS Degree in Chemistry or Pharmacy or Technology or related field.
- 5 years of experience in an FDA regulated manufacturing environment.
- 5 years of experience working in a Quality environment with comprehensive knowledge of cGMP and FDA regulations.
- Experience managing direct reports.
- Experience conducting/managing internal and external quality audits FDA audits customer audits.
- Advanced skills in Microsoft Office (Outlook Word Excel and Power Point).
Other Required Skills
- Ability to work independently and as part of a team.
- Strong attention to detail planning and organizational skills.
- Strong written verbal and interpersonal skills.
Preferred Qualifications:
- Six sigma certification.
- Professional course in Regulatory Affairs.
- Experience in an environment of highspeed assembly lines.
Physical Demands:
- Able to sit for long periods of time utilizing a computer.
- Able to stand for long periods of time on the manufacturing shopfloor.
- Exposure to dust noise and odors.
- Work may be performed in a manufacturing environment.
- Lifting up to 20 lbs.
Note:
The above statements shall not be construed as a complete description of all the work requirements.
VVF is an equal opportunity employer. We evaluate qualified applicants without regard to race color religion national origin sex or gender age disability veteran status sexual orientation gender identity or expression genetic information including the perception that a person has any of those characteristics or that the person is associated with a person who has or is perceived to have any of those characteristics or any other consideration made unlawful by applicable law. VVF is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process please call Human Resources at and let us know the nature of your request and your contact information.
Required Experience:
Manager
Employment Type
Full-Time
