Asst. Manager – External Preparation(P)

Job Description:

Position:          Asst. Manager – External Preparation(P)

Location:          Pariya - Vapi

Experience:      10 - 15 Years

Industries:       Pharma

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 equipment’s 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: - B.Pharm/M.Pharm

Salary :- Upto 12.00 LPA

If you are interested in this opening, please send updated resume on same mail with following details.

Total No. of Years Experience: -

Current CTC: -

Expected CTC: -

Notice Period: -