Senior Executive-QA

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Job Description

Key Roles and responsibilities:
• Monitoring of product quality, in-process control and manufacturing environment.
• Ensure effective implementation of system and procedure as per cGMP, ISO 13485 in shop floor, warehouse, and engineering along with documentation.
• Review all BMR, BPR for their correctness and retention until destruction.
• Review of quality records in periodical basis and review of analytical data in COA.
• Issuance of BMR, BPR, Cleaning checklists, Logbook and Labels as per requirement.
• Sampling of FG control samples, stability samples and other samples as per requirement along with related documentation.
• Responsible for alarm review and trending as and when required.
• Training of new employees, system practices and procedure to develop competency.
• Review and approval of executed batch manufacturing, packaging documents & other quality documents.
• Handling of material on shop floor through approval for MRN, LRN, and MRQN.
• Submission of In-process analysis report from QC to production after review.
• Handling of non-conformance.
• Online stage wise BMR/BPR review.
• Handling of Ensur, SAP & track wise activity as per Quality Assurance procedure.
• Handling of QAAS, CPV, CLEEN software.
• Approval of line clearance during product changes over/ Batch change over.
• To ensure the EHS (Environment, Health, and Safety) related activities to be completed on time and to support EHS activities as per requirement. To report near miss and incidences as observed as per EHS requirement.

Qualifications

Bachelor's Degree

About Us

In 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), ****** 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 Team

Piramal 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.

Job Info
• Job Identification 8570
• Job Category Quality Assurance
• Degree Level Bachelor's Degree
• Job Schedule Full time
• Locations Piramal Enterprises Limited, Plot # 67-70, Sector II, Dhar, Madhya Pradesh, 454775, IN