Job Description:

Urgent Opening for General Manager - QA / QC/Regulatory

Designation: General Manager QA & QC

Functional Area: Quality and Testing

Qualification : Ph D / MSc. (Analytical / Organic Chemistry)

Exeperience: 18-25 years

Reports To: Associate Vice President

Salary Range - As Per Norms

Location: Ahmedabad

Job Description :

As a General Manager QA & QC your responsibilities include the following

- Planning, Implementing and prioritizing Quality Control Systems and jobs as per Plant requirements w.r.t. Raw Materials, Packing materials, In process and Finished Products in coordination with R & D, Pilot Plant and QA.

- Establishing specification and Method of Analysis of Raw Materials, Packing materials, in process and Finished Products as per norms

- To train Staff, Operators and update their skills (cGMP, Safety, etc) and Trouble shooting

- Ensure completeness of documentation and validation of process and analytical methods as per cGMP requirements.

- To maintain discipline at all levels

- Coordination with Maintenance, Stores, Admn., Safety, Production

Desired Candidate Profile:

- Having 20 to 25 years of experience in QA & QC of API manufacturing @ Finish formulation

- Must have faced international audits like WHO Geneva, EDQM, MHRA, USFDA etc. in a leading role

- Should have an experience of closely working with Regulatory Affairs

- Should be working in a similar capacity (GM / Head-QA & QC) in API Sector having best QA & QC practices

- Should have strong Analytical Skills

- Knowledge of QA, QC analysis and interpretation of results, cGMP and GLP

- Analysis and Trouble shooting in analysis

- Managing Audits

- Knowledge of ISO 9000/14001

- Hard working, Positive Attitude, Excellent Communication Skills, Willingness to Learn

- Hands-on Approach, Energetic, Hardworking, Meticulous and Analytical

- Good Leadership qualities and Interpersonal Skills

- Strong presence of mind

Salary: As Per Norms

Industry:Pharma / Biotech / Clinical Research

Functional Area:Production, Manufacturing, Maintenance

Role Category:Production/Manufacturing/Maintenance

Role:Quality Assurance/Quality Control Manager

Employment Type: Permanent Job, Full Time

Keyskills

QA Management QC General Management Quality testing

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