QUALITY CONTROL SPECIALIST - Piramal Group : Job Details

Job DescriptionKEY RESPONSIBILITIES

• Design, develop, maintain, and initiate continuous improvement activities for the material specifications preparation/revisions and execution until it is processed for approval.
• Author and reviewer for test method review, risk assessments, change controls, SOPS, specifications, etc.
• Complete activities in compliance to applicable SOPs, specifications, and compendia requirements in an efficient and high quality manner.
• Evaluate compendia monographs, plan for and order reagents,supplies, instrumentation requirements
• Work closely with others in a team environment within the Quality Control Laboratory and act as an integral team member on multidisciplinary teams that provide support for Manufacturing and Product Development.
• Coordinates and participates in material review meetings and/or batch readiness meetings.
• Maintain schedule routine maintenance of laboratory instruments for follow up repairs and/or tracking the calibration activities for timely completion
• Working closely with validations team to complete the required tasks for Instrument qualifications process
• Required assistance on record keeping for Laboratory personnel training matrix updates periodically
• Purchasing of laboratory reagents and consumables.
• Perform testing, analysis and data reporting for test samples as needed.
• Inform budgetary decisions for material testing costs.
• Ensure maintenance and calibration of analytical instruments in compliance with SOPS and GMP regulations.
• Develop the Materials testing Training program for QC analysts and lead the training activities.
• Maintain regulatory compliance in instrumentation records, test result documentation, usage logbooks, maintenance logbooks and all other project or material specific documentation with particular attention to accurate record keeping.
• Perform all work according to applicable safety procedures using good laboratory techniques and using safe operation of laboratory equipment.
• Perform additional duties as assigned by laboratory management

QualificationsEducation Requirements:Bachelor of Science in Chemistry, Pharmaceutical Science, or other closely related scientific fieldWORK Experience:

• 5+ years of experience in a pharmaceutical laboratory or regulated environment
• Hands-on experience performing quality control work within a laboratory and operating analytical testing equipment
• Experience working with potent, cytotoxic materials and parenteral drug products preferred

Functional OR TECHNICAL Skills:

• Knowledgeable in general analytical techniques
• Knowledgeable in analytical testing equipment and related procedures.
• Knowledge of USP, FDA, and ICH requirements and procedures, EU/EP and PMDA experience a plus
• High proficiency operating analytical testing equipment and troubleshooting
• Ability to handle multiple assignments and projects with competing priorities while independently managing time is critical.
• Highly motivated, self-directed, detail oriented, quality minded with strong organizational skills.
• Operates with a sense of urgency in a fast-paced environment
• Ability to comprehend and follow standard operating procedures and test methods.
• Proficient in Microsoft Office Applications (Word, Excel, PowerPoint etc.), with ability to learn and master new computer applications.
• Strong technical writing skills
• Able to exercise independent intellectual judgment using data driven decision making
• Excellent oral and written communication skills

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.