Head Quality

HRD House; Mumbai; Vor Ort; INR 2.500.000 - 4.500.000; Vollzeit

Zusammenfassung

HRD House, a Palghar-based semi solids & liquid oral dosage form manufacturer, seeks a Quality Head (DGM/GM) for EU/MHRA approved formulation lines.

You will lead the Quality function at Tarapur site, drive QMS, manage deviations, CAPAs, OOS, vendor audits, and ensure equipment qualification, regulatory audits (EU, MHRA, TGA, ROW) and cross-functional collaboration for technology transfers and validations.

Qualifikationen

• 15–20 years in pharmaceutical industry with 5+ years in senior QA leadership.
• Experience in semi-solid and liquid oral dosage forms.
• Knowledge of GMP, ICH, WHO guidelines and regulatory expectations.

Aufgaben

• Lead and maintain a comprehensive QMS for Tarapur site.
• Oversight of deviations, CAPA, change control, and OOS investigations.
• Coordinate regulatory audits (EU, MHRA, TGA, ROW) end-to-end.
• Ensure equipment qualification, validation and SOP approvals.
• Collaborate with Production, QC, Eng, Regulatory Affairs and R&D.

Kenntnisse

QA leadership

GMP

ICH

WHO requirements

QMS

Ausbildung

M.Sc Chemistry

B.Pharm/M.Pharm

Jobbeschreibung

Role & responsibilities

You will be working as Quality Head as DGM/GM for EU, MHRA etc approved Formulation

Semi Solids & Liquid Oral manufacturing company based at Palghar/Tarapur.

Will be responsible for:

• He will Lead Quality function for their Tarapur site .

• He will be responsible for handling, developing, implementing, and maintaining a

  comprehensive quality management system (QMS) elements including :

  • Deviation, Change Control, CAPA, and OOS management
  • Quality Risk Management
  • Document and Record Control
  • Annual Product Review (APR/PQR)
  • Vendor Qualification and Audits

• You will be responsible for ensuring that all pharmaceutical manufacturing equipment and

  facilities are appropriately qualified and validated.

• You will be responsible for reviewing and approving SOPs for manufacturing, quality control, and other relevant departments.

• You will be handling all Regulatory Audits start to end, including, EU, MHRA , TGA,ROW

  etc.

• You will be work closely to with Production, QC, Engineering, Regulatory Affairs, and R&D teams and Support in technology transfers, process validations, and new product introductions from QA perspective.

Preferred candidate profile

• Candidate should have a M.Sc Chemistry or B.Pharm/M.Pharma with Minimum 15-20 years of experience in the pharmaceutical industry with at least 5 years in a senior QA leadership role in a regulated environment in Semi Soilds & Liquid oral dosage form.

• Candidate should handle key performance indicators (KPIs) to measure and report on the effectiveness of the quality assurance program.

• Candidate should have knowledge of pharmaceutical regulations, particularly GMP , ICH , WHO requirements.

• Candidate should be good in timely resolution and documentation of OOS/OOT investigations and QMS .

• Candidate should be good in handling Conduct internal audits and inspections to identify and address compliance issues.