This role will manage the development, establishment, and maintenance of Quality Systems, policies, processes, procedures and controls ensuring that performance and quality of cGMP documentation and records conforms to established standards for our 100 person state-of-the-art facility in Billerica, MA.
Area Of Responsibility
- Implement electronic Quality Systems, such as eQMS, EDMS, and LMS, providing procedures and training for employees to effectively use the electronic Quality Systems
- Design, plan, implement, and manage documentation programs, policies, and procedures that support company objectives and regulatory requirements
- Supervise the QA Documentation department in the creation, issuance, maintenance, archiving, and storage of cGMP and cGXP controlled documentation and records
- Manage electronic document processing, retrieval, and distribution systems (EDMS), electronic learning management system (LMS), electronic Quality Management System (TrackWise), etc.
- Administer document and system access rights and revision control to ensure security of system and integrity of master documents
- Lead Monthly Quality Review Board (QRB) meetings, Quality Investigation Board (QIB)
- Supervise the creation of an annual training calendar and other training initiatives at the site
- Provide expertise and input to other functional areas affecting controlled documents and records
- Assist with FDA and other compliance audits including corporate audits.
- Facilitate and follow up with stakeholders with regard to responses to audit observations
- Prepare annual internal audit schedule and perform execution of same
- Oversee site vendor management program including performing annual vendor risk assessment
- Oversee harmonization efforts between corporate and plant Quality procedures and policies
- Provide QA review of Annual Product Reviews (APRs) to identify trends and recommend CAPA as needed
- Provide QA review of quality events such as unplanned/planned deviations and change controls
- Participate in investigation team efforts to determine root cause for critical quality events and recommend appropriate CAPA
- Develop presentation materials for upper management to disseminate on the topics of quality issues, QMS
- initiatives, and related projects
- Participate in Regional Quality related projects and initiatives, acting as an ambassador between corporate and plant
- Issuance of Quality Alerts, FAR/Recall as per internal procedures
- Other duties as assigned
Education and Job Qualification
- B.S. in chemistry or related scientific field
- Minimum ten (10) years of related experience in pharmaceutical (manufacturing) environment, biotech industry, Quality Assurance, Quality Control and/or production, or FDA regulated industry.
Experience
- Strong working knowledge of a Quality Management System (QMS) and adherence to 21 CFR Parts 210, 211; aseptic drug manufacturing experience a plus
- Superior internal and external customer service/people skills
- Ability to manage multiple responsibilities and training projects in a fast paced environment, in an efficient manner
- Ability to present self in a professional, credible manner and communicate effectively at all levels of the organization
- Ability to prioritize and organize own work, multi-task, meet deadlines and keep commitments
- Experience in developing and managing various types of training initiatives expected
- Excellent administrative & organization skills
- Strong presentation and MS Power Point Skills
- Positive attitude; values others and works well independently and in a team environment
- Excellent verbal, written and interpersonal communication skills
- Works under minimal supervision following established procedures along with own judgment.
- Expert knowledge of electronically based Quality Systems
- Working knowledge of pharmaceutical and medical device documentation and change controls
- Experience with continuous improvement programs and project management skills
- Working knowledge of applicable domestic and international standards and regulations
Sun Pharmaceutical Industries Inc. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over $ 4.5 billion US Dollars. Supported by more than 40 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe including the United States. Sunology is a combination of Sun Values and Ideology and is the way of life at Sun Pharma. Sunology is Humility. Integrity. Passion. Innovation. It represents our promise to all stakeholders including patients, physicians, and employees.
Sun Pharmaceuticals offer a wide range of benefits including:
· Generous PTO + 11 paid vacation days
· Highly subsidized Medical, Dental, Vision Benefits
· Health Savings Account (HSA), Flexible Spending Account (FSA)
· Prescription Drug Coverage
· Telehealth and Behavior Health Services
· Income Protection – Short Term and Long Term Disability Benefits
· Retirement Benefits – 4% company 401k Match on Day One (100% vesting immediately)
· Group Life Insurance
· Wellness Programs
· Corporate Discounts on personal services: Cellular phones, Entertainment, and Consumer Goods
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 Taro employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Taro. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.
SUN PHARMA
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