Senior Executive-QA at Piramal

Thane, maharashtra, India -

Full Time

Start Date

Immediate

Expiry Date

30 Apr, 26

Salary

0.0

Posted On

30 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Data Integrity, cGMP, Analytical Data Review, Batch Release Management, Cleaning Validation, Line Clearance, Annual Product Reviews, QC Laboratory Activities, SOP Adherence, Deviation Investigation, Change Control, CAPA, Communication Skills, Teamwork, Attention to Detail

Industry

Financial Services

Description

Business: PPL Department: Quality Assurance Location: Navi Mumbai Travel: Low Job Overview As A Senior Executive – Quality Assurance is responsible for ensuring quality oversight and compliance of QC and manufacturing activities through thorough review of analytical data, batch records, and QMS elements. The role involves batch release management, review of electronic and manual QC data, and ensuring adherence to cGMP, data integrity, and regulatory requirements. The incumbent will also support cleaning validation, line clearance, dispatch activities, and preparation and review of Annual Product Reviews (APR) to ensure consistent product quality and regulatory compliance. Roles and Responsibility: •Review and evaluation of QC analytical data, including thorough electronic data and audit trail review to ensure data integrity. •Batch Release Management •Hands on analytical experience •Review of batch manufacturing and packaging records, including audit trail verification. •Preparation and Review of APR •Oversight and review of QC laboratory activities to ensure adherence to SOPs and quality standards •Initiation, investigation, and review of QMS elements such as Deviations, Change Controls, OOS, OOT, and CAPA •Verification of dispatch activities and line clearance to ensure compliance with GMP requirements. •Review and execution of cleaning validation activities in accordance with regulatory guidelines Preferred candidate profile: Masters/bachelor’s degree in chemistry or a related field. Basic understanding of peptide synthesis principles is a plus. Strong attention to detail and commitment to quality. Ability to work in a team-oriented environment. Good communication and interpersonal skills. Willingness to learn and adapt to new processes. 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. 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.

Responsibilities

The Senior Executive – Quality Assurance is responsible for ensuring quality oversight and compliance of QC and manufacturing activities through thorough review of analytical data and batch records. The role includes batch release management, review of QC data, and ensuring adherence to regulatory requirements.