Key Responsibilities
JOB DESCRIPTION
- Ensure strict adherence to cGMP standards, GDP requirements, and all factory safety rules.
- Issue BMRs/BPRs/ECRs to the Production department as per established procedures.
- Handle issuance and reconciliation of product labels, hard books, controlled formats, ropes, and tech-lock seals.
- Assist in the review of vendor qualification documents, BMRs, and ECRs.
- Maintain proper filing and organization of BMRs, ECRs, Approved Vendor Lists, and other QA records.
- Manage issuance and retrieval of controlled documents to/from various departments through ENSUR or applicable document control systems.
- Carry out routine shop-floor visits to ensure compliance with quality procedures and regulatory expectations.
- Perform line clearance and area clearance activities prior to manufacturing operations.
- Verify document drop box contents and coordinate secure destruction of documents as per procedure.
- Support review and approval of executed batch records and cleaning records of SRU operations.
- Ensure timely archival of QA documents as per SOP requirements.
- Assist in collecting and compiling data required for preparation of Annual Product Quality Review (APQR).
- Support the initiation, documentation, and tracking of change controls and deviations.
Responsibilities
Key Roles / Responsibilities:
- To assist in preparation, issuance, review, and control of SOPs, BMRs, and controlled documents.
- To support documentation of deviations, change controls, CAPA, and incidents in line with QMS.
- To ensure compliance with cGMP, QMS, and regulatory requirements during all QA activities.
- To participate in internal audits, self-inspections, and regulatory inspections.
- To follow ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available) in all documentation practices.
- To maintain and update QA logbooks, training records, calibration records, and archives.
- To support qualification, validation, and calibration documentation as per GMP guidelines.
- To assist in vendor qualification processes and related documentation.
- To participate in EHS (Environment, Health & Safety) initiatives and ensure workplace safety compliance.
- To report any deviations, incidents, and unsafe practices immediately to supervisors.
- To contribute to continuous improvement initiatives related to QMS, GMP, and safety standards.
- To support stability study documentation and ensure adherence to data integrity requirements.
Qualifications
- B.Sc / M.Sc in Chemistry
- Freshers or candidates with up to 1 year of experience in QA/QC/Production in the pharmaceutical or API industry.
- Basic understanding of cGMP, GDP, and pharmaceutical manufacturing processes (preferred).
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.
