Title:  IPQA Associate I

Job Summary

The IPQA Associate I is responsible for identifying deviations in the processes and ensure that all activities are cGMP compliant, identifying corrective actions, establishing path forward activities, and appropriate documentation.

Area Of Responsibility

Under extensive supervision:

• Focuses on initial deviation investigative phases related to manufacturing process deviation.
• Responds to customer calls for assistance, documentation and immediate corrective action associated with deviations.
• Facilitates the use of existing management processes regarding deviations, investigations, and preventive actions.
• Performs area assessments and ensures compliance with SOPs, Policies and Procedures.
• Leverage on-the-floor presence to proactively identify opportunities and provide coaching.
• Responsible for responding to customer needs immediately, ensuring appropriate corrective action is taken and process controls are in place.
• Work closely with Quality Engineers and QA Management to ensure thorough and complete investigation activities.
• Administration and management of deviations/investigation/PAC systems in Trackwise.
• Control materials for compliance purposes in SAP.
• Execute the final release inspection of packaging lines.
• Perform acceptance sample analysis for validation and investigation support.
• Responsible for the review and approval of controlled documents.
• Actively communicate with customers to facilitate continuous process improvement.
• May complete specific project work such as process improvement/remediation, maintain ownership and responsibility for specific QA processes.

Work Conditions:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job in an office, lab, or manufacturing environment. The noise level in the work environment is usually moderate.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this job, the employee is regularly required to use hands to handle or feel and talk or hear. The employee is frequently required to stand, walk, sit, stoop, kneel, crouch, crawl, push, and bend.
• Must be capable of bending and lifting, moving and/or carrying up to approximately 20 pounds.
• Ability to navigate office, lab, and/or plant floor working environments, stands, ambulates, and reaches.
• Must have the ability to wear applicable personal protective equipment utilized at the site, including but not limited to respirators, safety glasses/goggles, and safety shoes.

Travel Estimate

Up to     0%

Education and Job Qualification

• Minimum of Bachelor’s degree.

• Understanding of GMPs.
• Expertise in software applications such as: MS Word, MS Excel, MS Office, Windows, PowerPoint, Microsoft Outlook, Acrobat Reader, TrackWise or similar QMS, LMS (Learning Management System) etc.
• Knowledge of project management principles, practices, techniques and tools.
• Strong interpersonal and communication, both written and verbal, skills.
• Strong organizational and time management skills; must be able to prioritize and manage multiple assignments simultaneously.
• A self-starter with a hands-on approach and a can-do attitude.
• The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).

Experience

• Minimum two (2) years of experience within the pharmaceutical industry in quality function role.
• Experience working in an international multicultural matrix organization.

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives:

Sun Pharma / OHM Labs is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun Pharma. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.