Executive-QC

Job Description

Business: PPL Digwal

Department: Quality Control

Location: Digwal

Job Overview: To perform Quality Control actives as per GMP & Safety

Travel Requirements: NA

Reporting Structure

Reports to Manager - QC

Key Stakeholders

Internal: Production, QA, SCM, IT, Engineering & Maintenance, TSD & Safety

External: Customers

Experience

• 4-8 Year Experience in Quality Control Chemical and Instrumentation Analysis for In-process, Stability, Raw Materials, Working standard/Reference standard, Packing Materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule received from PPIC (API) as per Pharma Manufacturing GMP requirements.
  
  

Responsibilities

Key Roles & Responsibilities

• Responsible for performing the chemical and instrumentation analysis for In-process, raw materials, packing materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule received from PPIC.
• Responsible for allotting the work to the chemist within the QC department.
• Responsible for performing the calibrations of all instruments in QC as per the schedule.
• Responsible for maintaining all the documentation online.
• Responsible for maintaining the minimum stock for working standards, reference standards and impurity standards and ordering as and when required.
• Responsible for maintaining the minimum stocks for chemicals, reagents, glass wares and solvents required for analysis.
• Responsible for keeping instruments neat and clean and overall housekeeping in the FP section.
• Responsible for review of analytical data, calibration data, qualification data.
• Responsible for keeping all instruments within the calibrated status.
• Responsible to do the analysis, review and release on time to support the production.
• Responsible for reducing the lab incidences, repeat analysis and no Data Integrity issues.
• Responsible for real time data monitoring.
• Responsible for reviewing the analytical data received from external laboratory.
• Responsible for maintaining all the calibration certificates, qualification certificates, standard weight certificates and working/reference standard certificates.
• Responsible for maintaining the consumption records and traceability of working/reference standards.
• Responsible for OOS investigations, deviations and CAPA implementations
• Responsible for review of SOP’s , test procedures and specifications
• Responsible for providing the training on GLP/GMP to the employees working the section.
• Responsible for releasing the batches timely manner to achieve the site requirement.
• Responsible for preparing the COA’s as per the customer requirement
• Responsible for approving/rejecting the batches in SAP
• Responsible for Controlling the cost and operate within the approved budget.
• Responsible for maintaining the instruments in working condition and reduce the breakdown time of instruments.
• Responsible for carrying out the analytical method transfers, Method validations, Method equivalency study and Method verification activities.
• Responsible for keeping the critical spare parts of the instruments.
• Responsible for Safe working conditions and clean environmental practices.
• Responsible for usages of required safety appliances in the section.
• Responsible for coordination with QA/Production/PPIC/Warehouse/TSD for smooth dispatches.
• Responsible to train the contract persons and helpers on glassware cleaning.
  
  

Qualifications

B.Sc (Chemistry) / M.Sc (Chemistry) / B. Pharmacy / M. Pharmacy

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.

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