Job Details
Job Description
PRIMARY RESPONSIBILITIES
- Prepare technical documents, such as protocols, reports, technical assessments and inter-office correspondence and document in laboratory notebooks as required for projects and commercial production support.
- Compile and evaluate data using statistical software and transfer data into tables and prepare graphics for incorporation into documents. Perform data audit and proofreading of documents.
- Complete documentation and change controls for new master batch records and revisions to existing master batch records.
- Author and periodically update assigned Standard Operating Procedures (SOPs).
- Execute protocol sampling, in-process testing and monitoring of study batches to assist Technical Services scientists.
- Complete and document physical testing (e.g., particle size distribution, bulk and tapped density, loss on drying, pH, viscosity, capsule or tablet weight, thickness, hardness, friability, etc.) of study batches using a wide variety of testing instruments.
- Organize and execute qualification of alternate suppliers of API, excipients, packaging components, equipment change parts, process parameters, yield limits, hold time studies, etc.
- Perform or assist with laboratory scale studies, batches and experiments.
- Execute or assist in facility and process equipment qualification activities such as installation, operational and performance qualifications, periodic reviews, etc.
- Perform cleaning validation activities such as swabbing of equipment and documentation for cleaning validation and verification studies, clean and dirty equipment hold time studies, etc.
- Works only under general direction and able to work in a team environment with proven ability to work and communicate well with others.
- Other assignments and tasks as required. Work hours may extend into 2nd and 3rd shifts depending on project schedule.
- Maintain regulatory compliance within the function and follow site core values and policies as well as site safety, health, and environmental policies and procedures.
QualificationsQUALIFICATIONS/REQUIREMENTS - Minimum of an Associates degree in a scientific discipline (e.g., Chemistry, Biology, Microbiology, Engineering, Pharmaceutics or equivalent) with a minimum of 7 years experience in Technical Services, Process Engineering, Process Validation, Formulation, Quality Control, Manufacturing or related field in the pharmaceutical industry.
- Mechanical aptitude and experience in laboratory and production scale manufacture of solid oral, liquid and semi-solid dosage forms using equipment such as comminuting mills, high-shear granulators, fluid bed dryers, blenders, tablet presses, tablet film coaters, encapsulators, low and high-shear mixing vessels, homogenizers, pumps, packaging, etc.
- Experience in physical testing and sampling and laboratory scale and/or production scale equipment operation for solid, semi-solid and liquid pharmaceutical dosage forms.
- Demonstrated professional demeanor with good verbal, written, organization and attention to detail skills required.
- Good computer, statistics and mathematics skills. Experience in MS Office applications, Trackwise and statistical software applications such as JMP, Minitab or StatGraphics.
- Technical writing experience is required. High capability in producing detailed and accurate documentation, tables and charts as well as accurate data entry and auditing.
- Ability to work in a production environment using the required gowning and respiratory protection conditions.
- Preference for good problem solving abilities and can understand and make generalized and specific conclusions from project data.
- Ability to work effectively managing multiple assignments and manage priorities to meet established schedules and timelines.
- Must be proactive, resourceful and committed to continuous improvement.
About UsIn the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.
Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.
Equal employment opportunity Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.
We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.
About the TeamPiramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited's investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.