Quality Assurance Manager

JOB QUALIFICATIONS:

• BA/BS Degree in science field, e.g., Biology, Microbiology, Chemistry, Pharmacy, Engineering, etc. or equivalent combination of education and experience.
• Must have 10 years minimum experience in pharmaceutical industry working with solid oral dosage forms.
• Must be an effective communicator and understand written procedures.
• Strong leadership skills.
• Very knowledgeable in cGMPs, FDA regulations, and FDA guidance.
• Planning and organization; and ability to plan and manage multiple projects.
• Attention to detail.
• Excellent interpersonal and communication skills.
• High performance team and strong team player.
• Ability to work with all levels in the organization to maintain communication, action and promote cultural change to embed new ways of working.
• Able to work under pressure and meet deadlines.
• Computer literate.

POSITION RESPONSIBILITIES:

• Oversees and maintains the quality systems.
• Participate in management meetings.
• Develop, supervise, and train QA employees.
• Assist with hosting FDA inspections and external GMP audits.
• Ensure company conformance to Good Manufacturing Practices requirements.
• Supervise the update and maintenance of master batch records
• Supervise the development of raw material and finish product specifications.
• Handle customer complaints.
• Analyze quality data to detect unsatisfactory trends conditions and weaknesses in the quality system.
• Develop, implement, and maintain standard operation procedures through the Change Control Notice System.
• Review and approve Process validation, equipment qualification activities.
• Review and approve investigations, deviations, and change control notices.
• Coordinate the implementation of the Internal Quality Systems Audit program.
• Prepares, Reviews and assists with all documentation for international registration purposes.
• Recommend corrective and preventive actions.
• Maintain and develop effective collaboration with other departments.
• Develop and/or support strategies for continuous quality improvement in systems and products.
• Reviews and Approves BR’s and COA’s for finished product final disposition.
• Review product developments, protocols and reports from quality perspective for adherence to applicable regulations.
• Assure appropriate CAPA are implemented and tracked as part of the deviations/investigations.
• Review and approve NCMR for proper final disposition.
• Oversees deviations/ investigations to determine root cause and assure timely resolution.
• Assists with the QC product, material and component specifications as needed

PHYSICAL REQUIREMENTS:

• Adhere to all safety policies; includes wearing personal protective equipment when required
• Light physical activity performing non-strenuous daily activities of an administrative nature
• Including but not limited to: Sitting for greater than 75% of your time, standing and walking for up to 25% of your time
• Manual dexterity sufficient to reach/handle items and work with the fingers
• Use of hands to fingers for typing and other computer activity for up to 75% of your time
• Reaching with hands and arms, climb or balance, stoop, kneel, crouch, or crawl less than 25% of your time
• Ability to lift, up to 50lbs, less than 25% of the time