Quality Assurance Validation Manager

Wellington Foods Inc•Corona, CA

23h

About The Position

The QA Validation Manager works with Quality, Manufacturing, Maintenance, Sanitation, and Regulatory personnel to perform validations on facilities, equipment, processes, and cleaning. Job duties include developing validation plans for the entire facility, identifying areas of process improvement, and scheduling periodic auditing reviews of the facility. This position requires strong communication skills, computer skills, and experience in a management position. The Validation Manager is responsible for the development and implementation of the strategies for the qualification of the manufacturing process and equipment. The position reports to the Vice-President of Quality Systems. MAJOR FUNCTIONS & RESPONSIBILITIES: Lead the validation activities as part of the facility design, build and qualification project by hands-on work and support from specialist contractor(s) as required. Close liaison with the building contractors, engineers and vendors of facility and equipment items to ensure full and appropriate information is provided, along with vendor qualification protocols. Support FATs, SATs, IQ/OQ as appropriate of plant and equipment, reviewing documentation and advising team members to deliver best practice. Responsible for the oversight of ongoing (DQ, IQ, OQ, PQ) validation activities once production has commenced. Review of vendor protocols and creation or approval of in-house protocols and reports to deliver a complete package of qualification documentation. As some validation activities will be outsourced, you will maintain these relationships, monitoring KPIs so that performance and value for money is maintained. In addition to the contractors, manage other validation team member(s), including their performance, development, training and compliance. As a key member of the Quality team, contribute to the overall validation strategy for the site as well as act as a technical point of contact for internal and external personnel. Key contributor in the project team to validate the manufacturing unit, working full-time on design, build and qualification activities. Draft and review GMP documentation including validation documentation, SOPs, and training documentation. Train team members in procedures relating to validation as required. Understand the production schedule and work closely with Manufacturing and Scheduling to build a qualification schedule that delivers minimum interruption to manufacturing output. Work in a safe manner, ensuring full compliance to HS&E policies at all times. Participate in continuous improvement in the manufacturing facility to enable production to be conducted effectively and efficiently. Establish and maintain strong relationships with cross functional departments including Manufacturing, Maintenance, and Regulatory groups. Actively maintain and update knowledge and expertise of current developments, standards and operating practices within the Food, Dietary Supplement, and Pharmaceutical industries. May need to work with customers on compliance to FDA regulations. Assist with development of SOP’s and Training Programs. Participate in third-party audits regarding validation activities. Conduct root cause analysis sessions in order to facilitate and initiate corrective actions and preventive actions (CAPA) with manufacturing operations management. Develop, design, write standard operating procedures (SOPs) ensuring compliance with the company’s policies and FDA regulations. Adhere and enforce current Good Manufacturing Practices (cGMPs) and Good Documentation Practices (GDPs), safety, company rules, SOPs, and policies. The individual working in this position must possess a solid work track record and/or demonstration of scholastic attendance and achievement. Must be willing to accept additional assignments and responsibilities as deemed necessary by senior management.

Requirements

Prefer a 4-year college degree (BS or BA) in science (i.e. Biology, Chemistry, Biochemistry, Microbiology, Biotechnology, and/or Engineering etc.).
At least 5 years of work experience in a pharmaceutical, personal care, biotechnology, dietary supplements, food and/or beverage industry with the knowledge of Regulatory Compliance on equipment validation, cleaning validation, and manufacturing process validation.
1-2 years supervisory experience preferred.
Good working knowledge of 21 CFR Part 111 (Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements), 21 CFR Part 117 (Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Control for Human Food), and 21 CFR Part 210 & 211 Current Good Manufacturing Practice In Manufacturing, Processing, Packing, or Holding of Drugs and Current Good Manufacturing Practice for Finished Pharmaceuticals.
Good knowledge of Hazard Analysis and Critical Control Points and other food safety programs, quality assurance and manufacturing principles and procedures.
Ability to communicate effectively in writing and verbally with employees at all levels of the organization.
Ability to manage and prioritize multiple projects using effective organizational skills and judgment in an environment of frequently changing of customer products with the ability to work independently.
Ability to use Microsoft Office applications; specifically using Word to create and modify documents, Excel to record data and calculate results, and PowerPoint to prepare training documents.
Experience of participating in the introduction of new processes and equipment into a GMP manufacturing facility.
The employee in this position is regularly required to work at a desk, write and enter information into a computer.
The employee frequently is required to use a computer and keyboard and to communicate in person and by telephone.
The employee is required to read/review written documentation for extended periods of time.
The role-holder will be required to operate across the facility including within GMP environments. These are restrictive environments that require careful and controlled working methods, following a series of SOPs and wearing specialist clothing.
Weekend and out-of-hours work may be required from time to time.
Must be willing to accept additional assignments and responsibilities as deemed necessary by senior management.

Nice To Haves

1-2 years supervisory experience preferred.

Responsibilities

Lead the validation activities as part of the facility design, build and qualification project by hands-on work and support from specialist contractor(s) as required.
Close liaison with the building contractors, engineers and vendors of facility and equipment items to ensure full and appropriate information is provided, along with vendor qualification protocols.
Support FATs, SATs, IQ/OQ as appropriate of plant and equipment, reviewing documentation and advising team members to deliver best practice.
Responsible for the oversight of ongoing (DQ, IQ, OQ, PQ) validation activities once production has commenced.
Review of vendor protocols and creation or approval of in-house protocols and reports to deliver a complete package of qualification documentation.
Maintain relationships with outsourced validation activities, monitoring KPIs so that performance and value for money is maintained.
Manage other validation team member(s), including their performance, development, training and compliance.
Contribute to the overall validation strategy for the site as well as act as a technical point of contact for internal and external personnel.
Key contributor in the project team to validate the manufacturing unit, working full-time on design, build and qualification activities.
Draft and review GMP documentation including validation documentation, SOPs, and training documentation.
Train team members in procedures relating to validation as required.
Understand the production schedule and work closely with Manufacturing and Scheduling to build a qualification schedule that delivers minimum interruption to manufacturing output.
Work in a safe manner, ensuring full compliance to HS&E policies at all times.
Participate in continuous improvement in the manufacturing facility to enable production to be conducted effectively and efficiently.
Establish and maintain strong relationships with cross functional departments including Manufacturing, Maintenance, and Regulatory groups.
Actively maintain and update knowledge and expertise of current developments, standards and operating practices within the Food, Dietary Supplement, and Pharmaceutical industries.
May need to work with customers on compliance to FDA regulations.
Assist with development of SOP’s and Training Programs.
Participate in third-party audits regarding validation activities.
Conduct root cause analysis sessions in order to facilitate and initiate corrective actions and preventive actions (CAPA) with manufacturing operations management.
Develop, design, write standard operating procedures (SOPs) ensuring compliance with the company’s policies and FDA regulations.
Adhere and enforce current Good Manufacturing Practices (cGMPs) and Good Documentation Practices (GDPs), safety, company rules, SOPs, and policies.
Accept additional assignments and responsibilities as deemed necessary by senior management.