Manager - Quality Assurance, Sterile

Manager -Quality Assurance, Sterile Injectable Manufacturing Facility

Position Summary:

The candidate's responsibilities include the hands-on execution of various critical tasks in the Quality Assurance Group. The successful candidate is a leader, self-driven, works with minimal direction and has well-rounded experience in previous Quality Assurance roles. This position will also establish, review and approve key quality system-related documents and ensure continuous compliance at Nivagen.

• Develop and implement comprehensive quality strategies to ensure the consistent production of high-quality Sterile Injectable dosage form
• Enforce GMP compliance
• Ensure that all products meet regulatory requirements

Job Type: Full-time

Experience: 15+ years of pharmaceutical industry experience

(Minimum 10 years of hands-on experience in the generic pharma industry)

Qualification:

• Experience in generic pharmaceutical development with a good understanding of the Sterile Injectable drug development process
• Strong knowledge of regulatory requirements for Sterile Injectable dosage forms
• Expert knowledge of cGMP, ICH, USP, and FDA quality guidelines and regulations
• Effective oral and written communication skills.
• Experience in handling QA activities for aseptically manufacturing of Pre-Filled Syringes (PFS), Small Volume Parenteral Products- Vial (Liquid & Lyophilized) & Ampoule, Large Volume Parenteral Products- Bottle & Bags.
• Preparation, review and approval of standard operating procedures (SOPs).
• To conduct review and approval of: ▪ Master BMR, BPR, protocols and reports ▪ Master Formulation Records (MFRs) and Master Packaging Records (MPRs) ▪ Trial batch records, protocols and sampling protocols and hold time study protocols. ▪ Equipment qualification (IQ, DQ, OQ & PQ) validation protocols and reports. ▪ Stability study Protocols & reports.
• Review and Approval of executed Media Fill Batch records and Protocols & actively involved in media fill failure investigations.
• Review and approve internal and external Deviations, Change Controls, CAPA and OOS and other relevant protocol related to method validations, product specific protocols and reports, executed BMRs and BPRs. Review and finalization of microbial specifications. Review of aseptic operation/microbiology related procedure, validations, additional studies and investigations.
• Review and Approval of Non-Conformance Reports for non-compliance issues that occur during production activities and ensure thorough investigation, root cause analysis, and corrective and preventative action.
• Perform third party audits of contract manufacturers, packagers, testing laboratories, and distributors
• Audit exposure: experience in internal and external audit management and related documentations.
• QMS activities, familiarity with SAP, Track Wise, Document Management System (DMS), and Laboratory Information Management Systems (LIMS) preferred.

• Candidate should have valid passport
• for more details please visit our website https://www.nivagen.com/