Executive Job at Enzene Biosciences | MPharm Graduates Apply Now
Enzene Biosciences Ltd. is hiring an Executive – QA – IPQA for its advanced biopharmaceutical facility in Pune, Maharashtra. This Executive Job is designed for M.Pharm or M.Sc. graduates with 3 to 6 years of experience in the biopharmaceutical industry. The successful candidate in this MPharm Job will provide in-process quality assurance oversight for drug substance (DS) manufacturing, ensure ALCOA+ data integrity compliance, and manage validation protocols and QMS documentation. For professionals seeking an executive role as their next job, this opportunity provides significant responsibilities and growth.
- Job Title: Executive – QA – IPQA
- Location: Pune, Maharashtra, India
About The Company
Enzene Biosciences Ltd., a subsidiary of Alkem Laboratories, is an innovation-driven biopharmaceutical company located in Pune, India. Enzene is known for its “Enzene Connected” manufacturing platform and its state-of-the-art facility designed for the end-to-end development of complex biologics and biosimilars. The organization prioritizes operational excellence, high-quality standards, and compliance with global regulatory benchmarks like the USFDA and EMA. Moreover, the company has gained recognition in the industry for its executive job opportunities and robust career advancement options.
Roles & Responsibilities
IPQA & Manufacturing Oversight
- Perform line clearance activities for new batches, dispensing of raw materials, cell bank issuance, and handling of Drug Substance (DS). If you are considering a move to an executive job, these diverse responsibilities align perfectly with your ambitions.
- Provide in-process QA oversight during manufacturing operations to ensure compliance with approved procedures and GMP requirements.
- Review and approve batch manufacturing records (BMRs) and batch documentation for completeness, accuracy, and compliance.
Analytical QA & Data Integrity
- Review analytical QC documents and ensure compliance with approved specifications and test procedures.
- Perform audit trail reviews for critical QC instruments and relevant process equipment to ensure data integrity (ALCOA+ compliance).
- Support and manage QA activities using eDMS and other digital quality systems. Successfully completing these tasks will expand your skillset, which is essential for career progression in any executive job role.
Validation & CPV Review
- Review Continued Process Verification (CPV) data and ensure trending and compliance. Additionally, showing initiative in these core areas can distinguish you as a standout candidate for an executive job opportunity within the quality assurance field.
- Review Process Validation Protocols and Reports.
- Review Cleaning Validation Protocols and Reports to ensure effectiveness and regulatory compliance.
Deviation, Breakdown & Complaint Handling
- Handle breakdown-related QA activities, including acknowledgement and receipt of complaints from user departments.
- Support investigation, documentation, and closure of quality events related to manufacturing and QC operations. Expertise in handling such issues effectively is a sought-after quality that can lead to new executive job assignments.
Documentation & QMS Support
- Prepare, review, approve, and control SOPs and quality documents in line with QMS requirements.
- Ensure timely documentation, version control, and compliance with regulatory expectations. Accurate documentation supports business continuity and is an essential skill for anyone in an executive job position.
Qualification
- M.Pharm graduates frequently pursue executive job opportunities in the pharma sector is required for the MPharm Job.
Experience
- 3 to 6 years of experience in the biopharmaceutical industry is preferred by most employers hiring for an executive job in QA or manufacturing oversight roles.
Skills & Competencies
- Strong experience in IPQA activities and analytical document review is vital for excelling in an executive job capacity.
- Sound knowledge of cGMP and data integrity principles
- Experience with eDMS / electronic quality systems is highly valued when applying for an executive job at leading organizations.
- Good understanding of validation, CPV, and batch documentation.
