The Associate II, Compliance is responsible for conducting activities to ensure site compliance to cGMP regulations as well as internal quality procedures. The Associate II Compliance is responsible for managing and conducting Investigations, Product Quality Complaints, CAPAs, Deviations and Change Controls. Ensures adherence to SOPs and policies. Provide assistance during regulatory, corporate and internal audits.
Area Of Responsibility
Conducts Investigations of Site Incidents/Deviations and Product Quality Complaints in Trackwise system and provides final review.
Ensures a robust deviation management program is executed to ensure effective root cause analysis and corrective and preventative action identified and completed
Reviews and approves Change controls, CAPA and Global CAPA and monitors the effectiveness of CAPA.
Handles Quality Metrics Management - responsible for the collection and reporting of Quality Metrics. Trending of Site Incidents, Product Quality Complaints, Change Controls, Out of Specifications, Out of Trends and CAPA on monthly, quarterly and annually basis
Assists in ensuring FDA Readiness Plan for the facility. Provides support for all regulatory audits, internal/external inspections, and other audits. Responsible for follow ups on all related Operational findings from FDA, other regulatory bodies, internal audits, etc.
Participates and conducts mock inspections to prepare the facility for audits and assesses gaps in the system; review documents for compliance to current regulations and cGMPs.
Identifies compliance issues and supports the implementation changes for constant improvements.
Supports adherence to SOPs and policies and assists in ensuring that procedures reflect current practice. Create new SOP's and revise the existing SOP's as applicable.
Reviews and approves Qualification Protocols and Reports for equipment and product validations/verifications.
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 5%
Education and Job Qualification
Minimum of Bachelor's degree.
Demonstrated ability and knowledge of QMS and driving investigations to completion.
Thorough 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.
Strong knowledge of project management principles, practices, techniques and tools.
Excellent interpersonal and communication, both written and verbal, skills.
Excellent organizational and time management skills; must be able to prioritize and manage multiple assignments simultaneously while working independently or with others as needed.
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 five (5) 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 Pharma 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.