Aurobindo Pharma USA Hiring For Quality Assurance Manager/senior Manager/director at East Windsor, NJ, United States , United States Full Time

Job Description

Division Overview:
Aurolife was founded in 2008 as part of a group of companies that has a long history of excelling in generic pharmaceutical product development and manufacturing. Aurolife has a 10 year history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization has give Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a robust pipeline of products. Aurolife’s aim is to provide healthcare at economical prices to make this a healthier world to live in.

Job Overview:
Responsible for cGMP compliance ensuring all FDA regulations, internal procedures and other regulatory requirements are adhered to as it relates to production support and documentation. Ensure all commercial products manufactured, processed, packed, or held at the site meet requirements for product identity, strength, quality, and purity, including products for regulatory submission. In addition, manage, direct, and mentor QA/QC staff.

Responsibilities:
Promote a positive quality culture and oversee on-the-floor quality presence in the respective business area (e.g. manufacturing and Quality Control Labs).

Provide quality direction for complex business and operational issues or technical challenges. Remove barriers as they arise.

Oversee data integrity for paper based and electronic systems, including quality review of audit trail reviews. Ensure compliance with applicable standards and regulatory guidelines (e.g. 21 CFR Part 11 related to computer systems).

Review/approve standard operating procedures, batch records, specifications, validation protocols and reports, instrument acquisitions/decommissions, work orders, as applicable. Ensure processes are harmonized across multiple business areas.

Serve as key quality resource in lead teams and/or other forums as required and provide compliance guidance to manufacturing and other supporting business units.

Collaborate with cross-functional departments during planning and process/continuous improvement projects and initiatives to ensure timely completion (e.g. quality plans objectives and milestones).

Identify and lead process improvement projects impacting multiple business areas.

Provide quality oversight for technology transfers to Aurolife /eugia facility.

Oversee and monitor Quality metrics. Ensure data compiled is communicated in relevant forums and escalate compliance issues to Quality senior management.

Mentor, coach, and manage staff performance and development.

Plan, administer, and monitor the department budget.

Qualifications – Skills & Requirements:
Experience at a sterile manufacturing site is required

Aseptic processes and associate validation experience

Technical and leadership responsibility Special knowledge or skills needed and/or licenses or certificates required

Expert knowledge of GMPs in the US and global pharmaceutical industry

Excellent hands-on experience with implementing and managing Quality/Compliance systems and processes (infrastructure)

Proven track record of successful interactions with the FDA and other health authorities

Experience with the execution, coordination, and tracking of Quality Management Systems (QMS) procedures and related activities

Proven people management experience . Ability to influence without direct authority

Education & Experience:
Bachelor’s degree in a Science or related field

8 years of experience in the pharmaceutical or biotechnology industry in quality or compliance positions

Physical Requirements: OFFICE POSITION – While performing the duties of this job the employee is required to: .Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment .Specific vision abilities required by this job include close vision requirements due to computer work .Light to moderate lifting is required .Moderate noise (i.e. business office with computers, phone, and printers, light traffic). .Ability to sit at a computer terminal for an extended period of time Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met. Additional Physical Requirements:

No Additional Requirements

Blood/Fluid Exposure Risk: Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment. We Are An Equal Opportunity Employer: Aurobindo Pharma USA, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.