Executive - Quality Assurance

Job Description

Job Description Preparation and updation of Validation Master Plan (VMP) Preparation of Process validation, Computer system validation protocol and report. Preparation of product matrix and Cleaning Validation/verification protocol and Report. Preparation of qualification and requalification protocol and report for processing equipment/instrument, utilities, and facility. Preparation of area validation protocol and reports. Preparation and review of quality risk assessments. Review of calibration certificate (External/internal). Preparation, issuance, review & archival of BMR/BPR. Batch Record storage, retrieval & destruction. Preparation of APQR. Line Clearance for Manufacturing, Packing & Dispensing activity. Sampling of Bulk and Finished goods. Review of production records and Finished Goods verification. Online observation of process deviation and effective implementation of CAPA. Management of Change Control / CAPA / Incidences. Handling of Change Control and follow-up for the implementation of Changes. To coordinate & maintain change control, deviation records. Complaint handling. Preparation and updation of Q.A departmental SOPs and loading it in DCS (Document Control System) ENSUR 4.2 To give training as per the Training schedule. To coordinate training program of the company along with HR, including on Job Training. Documentation Management as per SOP. To provide necessary documents / data required by CQA and as per customer’s requirement. Conduct, monitor and review of compliance of Self Inspection Program. Audit compliance coordination, to compile CAPA and prepare response to Audit report in co-ordination with QA Head and technical team. Execution of requirements for food / Dietary supplements regulations for export market (US)-21 CFR Part 111 Ensuring avoidance of breach of data integrity in area. Implementation of effective sanitation programme in area. Adherence to the requirements of EHS norms. Execution of various initiatives as are suggested by corporate functions. To determine internal and external QEHS issues as well as needs and expectations of relevant interested parties and monitor the same. Qualifications B. Pharm or M. Pharm 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), 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 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 7876 Job Category Quality Assurance Posting Date 05/28/2025, 10:03 AM Degree Level Bachelor's Degree Job Schedule Full time Locations Piramal Enterprises Limited, Plot no. K-1, Mahad, Maharashtra, 402302, IN Show more Show less