Job Summary
Responsible for batch certification review of site QA activities related to manufacturing batch records, packaging records, QC lab records, certificates of analysis/compliance and all related supporting documentation (i.e. documentation review, SOP compliance, laboratory application data reviews, batch release, equipment/ instrument preventive maintenance/ calibration/ qualification/ validation as per good manufacturing practices/ good documentation requirements and ALCOA++ principles). Provides supporting role during regulatory, corporate and internal audits.
Area Of Responsibility
Supports Batch certification activities related to USA/Canada commercial distribution in a timely manner. Ensures activities are aligned with schedule and deliverables.
Conducts Investigation reviews of Site Incidents/Deviations (planned, unplanned deviations, OOS/OOT investigations, FARs). Ensures Corrective and Preventive actions are adequate.
Ensure compliance to regulatory requirements on product, process, equipment and release procedures.
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.
Performs additional assignments as needed.
Work Conditions:
Corporate Office Environment
Manufacturing / Production Environment
Laboratories
Warehouse Environment
Field Familiarity Environment
Physical Requirements:
Must be capable of bending and lifting, moving and/or carrying up to approximately 10 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 10 %
Education and Job Qualification
Minimum of Bachelor's degree
Role supporting seminars and courses are an asset.
Thorough understanding of GMPs, specifically those relating to good documentation practices
Ability to work effectively in an international multicultural matrix organization
Expertise in software applications such as: MS Word, MS Excel, MS Office, Windows, PowerPoint, Microsoft Outlook, Acrobat Reader, TrackWise, LMS (Learning Management System) etc.
Knowledge of project management principles, practices, techniques and tools
Strong communication, interpersonal and organizational skills
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 of seven (7) years of experience within the pharmaceutical industry
Experience working in an international multicultural matrix organization.
Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.
The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.
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 Pharmaceuticals (Sun) 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. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.
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