Manager - Quality Control

Piramal Pharma; Pithampur; On-site; INR 1,800,000 - 3,200,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Manager - Quality Control to lead LIMS master data review and oversee QC operations across finish, stability, and in-process samples. This role ensures accurate data handling and adherence to GMP standards in a fast-paced CDMO environment.

You will ensure SAP data entry, plan analyses, supervise staff, review OOS/OOT, and ensure compliance with IP, BP, USP and other pharmacopeia; strong focus on data integrity and a culture of quality.

Qualifications

• Knowledge of cGMP requirements and pharmaceutical QC standards.
• Ability to review OOS/OOT and incidents and perform investigations.
• Experience with data integrity and regulatory guideline implementation.

Responsibilities

• Review and release semi-finished products in SAP.
• Plan analysis of finish products and stability samples.
• Allocate work based on staff skills and supervise.
• Review OOS/OOT and incidents and investigations.
• Perform QC lab self-audits.
• Ensure audit trails in QC instruments.
• Maintain QC laboratory records.
• Provide on-job training to develop skills.
• Ensure cGMP in QC lab.
• Support Data Integrity Compliance Officer.

Skills

cGMP compliance

QC data review

team supervision

OOS investigation

SAP data entry

Tools

SAP

QC instruments

Job description

Job Title Manager - Quality Control

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients 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 like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide. For more details, please visit : www.piramalpharmasolutions.com

Job Description LIMS Master data review

• Ensure analysis of Semi Finish Product, Stability samples, In Process and Blend Samples and related documentation as per cGMP requirement.
• Ensure entry of data in SAP and release of semi-finished products in SAP.
• Plan the Analysis of Finish Product and stability samples as per cGMP requirement in time.
• Allocation of work as per the skills of persons and supervision.
• Review and approve OOS, OOT and Incident of QC laboratory and carry out OOS investigation.
• To review and ensure effective implementation of regulatory requirement, guidelines and pharmacopeia changes like IP, BP, USP, Ph. Eur, JP etc.
• Review of work output and pending work.
• To perform self-audit of QC Laboratory on periodic basis.
• Ensure analysis of Raw Materials / Finished Products as per requirement from Outside Commercial Lab.
• To check audit trail in QC Instruments.
• Ensure compliance to KRA’s and other such assignments.
• To control and maintain QC Laboratory Records. (Like Laboratory note Book, Chromatograms, and COA etc.).
• On job training as necessary to develop skills and improve productivity.
• To ensure cGMP in quality Control laboratory.
• Support to site DICO (Data Integrity Compliance Officer) for monitoring and implementation of actions related to Data Integrity awareness at site.

Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the- counter products. In addition, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group.

PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.