Asst. Manager - External Preparation (P)

Quality HR Services

10 - 15 years

10 - 12 Lacs

vapi

Posted:1 day ago| Platform:

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Skills Required

production auditing gmp internal audit manufacturing standard operating procedures hvac team management regulatory documentation technology transfer cfr process compliance automation tools sop qms quality assurance doc vendor audit

Work Mode

Work from Office

Job Type

Full Time

Job Description

Responsibilities:

Production & Compliance:
Oversight of External Preparations, and Oral Liquid Finished Formulations
Ensure adherence to batch manufacturing records (BMR), batch packing records (BPR), and standard operating procedures (SOPs).
Monitor and optimize production schedules to meet output targets and minimize downtime.
In-process Quality Assurance (IPQA) and documentation control (DOC - QMS)
Handling regulatory audits and ensuring compliance (PICs, EU, MHRA, WHO GMP etc.) electronic documentation systems including E-BMR, E-BPR, and E-Logbooks.
Lead deviation investigations, CAPA implementation, and change control processes.
Technical Expertise:
Execute and document Design Qualification (DQ), Installation
Technology Transfer (TT) and 21 CFR Part 11 compliant software systems
Validation protocols: HVAC, Water, Equipment, and Computer System Validation
Preparation of Risk assessments:
Preparation of Validation protocol, report, M/C qualifications for the new equipments and Utilities
Knowledge to handle QMS documents like Investigation, Deviation, Market complaint, CAPA, Incidents
Digital Systems & Automation:
Experience with Electronic Batch Manufacturing Records (E-BMR), E- Logs, and QMS platforms
Knowledge of atomization processes and automation tools Leadership & Audits:
Team management and cross-functional coordination
Conducting internal audits and vendor audits with corrective action planning
Regulatory experience to face the various audits

Required skills:

Strong knowledge of external dosage forms manufacturing.
Familiarity with regulatory requirements (USFDA, MHRA, WHO, EU GMP, etc.).
Good understanding of GMP documentation and compliance processes.
Team leadership and problem-solving abilities.
Attention to detail and result-oriented mindset.

Required Qualification: -

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