Senior Executive-QA

Job Description

LOCATION: Digwal

JOB OVERVIEW: To review the analytical reports and handle investigations incidents.

KEY STAKEHOLDERS: INTERNAL:

Quality Control, R&D , Technical Services , Regulatory Affairs

KEY STAKEHOLDERS: EXTERNAL: Customers

REPORTING STRUCTURE: Manager – Quality Assurance

ESSENTIAL QUALIFICATION:M.Sc. (Analytical / Organic Chemistry / B. Pharmacy / M. Pharmacy

Relevant Experience

Minimum 5 years of experience in review of analytical data handling, audit trail review. Knowledge of investigations incidents , OOS ,OOT, LI and route cause analysis, Handled sophisticated instrument of QC like HPLC, GC, LCMS etc.

Responsibilities

KEY ROLES/RESPONSIBILITIES:

Review of In-process analytical data before release.

Review of Intermediates, stability batches and Finished products analytical data.

Having the knowledge on the analytical method validations and method transfers.

Review of System audit trails for all the types of instruments in QC.

Review of the calibration data of the instruments on daily basis.

Verifying the SOP’s compliance in shop floor.

Carry out the audits as and when required for laboratory system compliances.

Investigation of the incidents, OOS, OOT & Root cause analysis.

Key Competencies

Handling of audit trails on all types of instruments

Handling of method transfers and method validations

Knowledge on review of analytical documents.

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.