What are the responsibilities and job description for the Lab Information Systems Specialist position at SUN_PHARMA?
COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE!
- 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 - 401k Company Match on Day One (100% vesting immediately)
- Group Life Insurance
- Wellness Programs
- Corporate Discounts on personal services: Cellular phones, Entertainment, and Consumer Goods!
Sun Pharma Vision: Reaching People And Touching Lives Globally As A Leading Provider Of Valued Medicines
Sun Pharmaceutical Industries Ltd. (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.
Our Code of Conduct
Our Global Code of Conduct governs every aspect of our operations. Sun Pharma is a family of thousands of people, working across many countries, speaking multiple languages, and all united, with one common purpose: to make good health accessible and affordable to local communities and society at large. Through active fieldwork, dedicated research teams, and in recognition of the efforts who work behind the scenes to combat illness and disease, the Sun Pharmaceutical Group helps as many people as possible, to secure their right to good health. The way we work every day is important to us.
DOWNLOAD OUR CODE OF CONDUCT
The Laboratory Information Systems Specialist is person with pharmaceutical chemist experience, will act as SME, and will play a key role in the implementation of LIMS other laboratory system. This position will also responsible to create specifications masters in SAP system and creating specifications and methods in LIMS.
- Lead implementation of laboratory Information Management System (LIMS) and other laboratory systems in QC Laboratory.
- Act as LIMS Subject Matter Expert and provide training to users.
- Optimize laboratory systems to align with LIMS practices and create/modify Laboratory SOP’s accordingly.
- Transfer laboratory specifications and methods from DCM system to LIMS.
- Ensures that the integrity and accuracy of all laboratory documents are maintained; must assess overall document compliance with protocols, SOPs, company policies, and applicable regulations.
- Crate new and update current method and specifications in the LIMS.
- Create specification maters in SAP system and create different quality views.
- Act as Writes of technical documents such as methods, specifications and department SOP's
- Generates change requests required for analytical documents, and routes documents for review and approval. Maintains hard copies and electronic file of technical documents.
- Timely provide the QC documents required for CBE, PAS and ANDA submission to RA.
- Collaborates with colleagues and external partners to achieve individual and department goals.
- Ensure continuous laboratory compliance by adopting best industry practice and complying with procedure requirements.
Qualifications
- Minimum BS or equivalent degree in Chemistry or related discipline.
- Minimum of four (8) years of experience in the pharmaceutical industry.
- Degree in computer software is preferred.
- Experience as a chemist with hands on experience with HPLC, GC, UV-VIS, dissolution etc
- Advance computer skills, and competence with Microsoft Office (Word, Excel, PowerPoint) and Access.
- Must have an understanding of FDA guidelines, ICH guidance and DEA regulations. Ensures compliance with cGMPs, DEA regulations, safety and site operating procedures under the direction of Management.
- Must be familiar with proper cGMP practices for analytical laboratories and working knowledge of basic laboratory instrumental analysis and wet chemistry skills.
- Collaborates with colleagues and external partners to achieve primary Department goals.
- Works in coordination with project plans and goals as assigned by Management.
- Demonstrated strong communication: verbal, written and presentation skills.
- A self-starter with a hands-on approach and a can-do attitude.
- Excellent project management and problem solving 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).
