Assistant Manager, Compliance

at  Aurobindo Pharma USA Inc

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.

QUALIFICATIONS - SKILLS & REQUIREMENTS:

Experience with Microsoft Office products, such as Excel, Word, and Outlook.
Strong planning, organization and prioritization skills with an ability to lead a team of mechanics.
Ability to work independently with minimal direction and supervision.
Intermediate ability to write reports, justifications, procedures, work orders and investigations.
Must be able to communicate effectively with departmental staff, both written and verbal.
A strong work ethic, integrity, stability, sense of urgency, fairness, and a desire and willingness to take ownership and assume responsibility for the operation.
A team player with a cooperative and logical workstyle.

EDUCATION & EXPERIENCE:

Prior experience in a pharmaceutical, biopharmaceutical or other GMP regulated industry.
Boiler Operator Certificate is a must.
Minimum of 5 years experience in CGMP, QMS and Internal/FDA Audits.
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:
Job requires you to worker to reach or work above the shoulder
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

Manage the team to schedule work orders based on the priorities and ensure all documentation is compliant with Good documentation practices.
Ability to check and respond to the BMS/EMS alerts.
Understand quality systems to include; Change Control, Deviations, CAPA’s, Investigations and Audits.
Plan and maintain spares and consumables for min-max and re-order levels.
Schedule and coordinate periodic maintenance work / calibrations with external agencies as applicable.
Adept in using CMMS and ERP.
Must train people on the SOP belonging to respective departments by preparing question banks, initiating a self-study course or offline course or external training in Nichelon.
Preparation of master equipment list.
Preparation and finalization of preventive maintenance checklist and schedules.
Preparation of master calibration list and calibration schedules.
Ensure the execution of preventive maintenance and calibration schedules with internal or external sources.
Review and verification of all calibration certification details and their archival.
Issuance, execution and archival of all approved documents on timely basis as per respective SOPs.
Develop procedures to induct new machines and maintenance procedures and coordinate with stake holders to ensure safe and compliant installation on time.
Increase Safety Awareness and address any safety issues and concerns and ensures that equipment m.eets all relevant Health, Safety and Environment requirements