Home Production Manager QA | Acme Formulations | Baddi, HP | 10.00-14.00 Lakhs

Manager QA | Acme Formulations | Baddi, HP | 10.00-14.00 Lakhs

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A Leading Pharma Group with Global Presence and approvals from EU-GMP, MHRA-UK, ANVISA Brazil, PICS Ukraine, WHO Geneva, INVIMA Colombia, USFDA*

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We have 3 facilities in North India and 1 R&D center at Bengaluru,

1. Immacule Lifesciences- Manufacturing of Liquid and Lyophilized injections approved from MHRA, ANVISA, PICS Ukraine, USFDA

2. Acme Formulation Pvt Ltd- Comprises of 2 blocks (General & Hormone), manufacturing Tablets, Capsules approved by WHO Geneva

3. Acme Generics LLP – Comprises of 2 blocks (General & Thyroxine), manufacturing Tablets, Capsules approved by EU-GMP

Position: Manager Quality Assurance

Location: Baddi, Himachal Pradesh

Job Description:

  • To ensure cGMP Compliance in the plant.
  • To review and approve all departments Standard Operating Procedures.
  • To ensure compliance of all Standard Operating Procedures.
  • Strategic Planning & execution of the Quality Management System.
  • To ensure the compliance of the Quality Management system as per the requirement.
  • Responsible for leading the external audit & providing compliance in a timely manner.
  • To review and approve the Site Manager File (SMF), Validation Master Plan(VMP), and Quality manual.
  • Responsible for the approval and release of the Batch.
  • To review & approve specifications, Standard Test Procedure (STP), and General Test Procedure (GTP) of the Quality Control Department.
  • Responsible for Self Inspection or Internal Audit and its compliance.
  • To review and approve all Validation and Qualification Protocols and Reports.
  • To ensure the compliance of Vendor Audits and approval of Contract Laboratory.
  • To perform laundry audits in coordination with the HR department.
  • To impart training on different topics including cGMP and GDP etc.
  • To coordinate during the technology transfer of products to the sites.
  • To ensure that products are manufactured as per the approved procedure.
  • Responsible for the investigation of the market complaints, Product recall & its compliances.
  • Responsible for review, approval and implementation, and verification of Corrective Action and Preventive Action.
  • To provide the compliance reports of audits.
  • To give the final approval for Art Works.
  • To conduct an interview and recruitments of Quality Assurance Personnel.
  • To ensure the Qualification and Re-qualification of the Equipment, Facility, and System
  • Responsible for review and approval of Stability Protocol and report.
  • To ensure work discipline in the department.
  • Responsible for quality agreement and its compliance.
  • To review and approve all apex documents.

Qualification: B.Sc/B.Pharma, MS/M.Sc/M.Pharma

Experience: 10-15 Years

Salary: 10,00,000 to 14,00,000 INR CTC/PA

Contact Details:

01795-248312

hr@acmegenerics.in, rahul.verma@acmeformulation.com

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