Job Description

Position:Quality Head

Location:Ahmedabad

Experience:20 - 25 Years

Industries:Pharma - Formulation

Responsibilities:

• The role is to Head the Quality Assurance & QC function of the company.
• Leads Validation, IPQA, Audit, QMS and Compliance and documentation vertical in QA function.
• Review and approval of master validation plan, drawings, layouts, URS, DQ, FAT, SAT,IQ, OQ, PQ, etc.
• Responsible for defining, implementing, managing and controlling all quality assurance systems in order to ensure quality of the product in compliance with established procedures and regulatory requirements.
• Ensure that adequate controls on starting materials, intermediate products, and bulk products, finished products and other in-process controls, calibrations, and validations are carried out.
• Ensure product release according to established procedures and after certified by authorized person.
• Work across all cross functions to ensure that the Company maintains a state of readiness for inspection by regulatory authorities
• Conduct regular training programs
• Tracking, reporting of quality performance indicators (KPIs) that measure the quality and compliance on a routine basis and identified risks related to quality and compliance
• To ascertain Quality of recalled product and performing in depth evaluation for reasons for recall
• Ensure periodical verification of quality system by way of internal audits and handling of regulatory inspections and customer audits.
• Provide Quality inputs for facilities during design/project phase.
• Contributing to team effort by accomplishing results as needed.
• To ensure compliance of quality documents and regulatory requirements.
• Vendor qualifications
• To assist in development of strategic and technical quality plans on support of the GMP.
• Address quality related issues and report key findings to MD.
• To ensure documentation control for equipment and service providers.
• To review technical documents for quality, correctness and completeness.
• Conducting the risk assessment with cross functions where applicable.

Required Skills

• Candidate should be on same designation for more than 3 years. Candidate should thorough in QA as well as QC in formulation Plant.
• Excellent communication skills in English.
• Expertise in regulatory audit preparation and acting as lead to successfully clear the audits.
• Preference shall be given to candidates who have independently faced and cleared audits.

Required Qualification: - M.Pharm/ M.Sc - Chemistry

Salary :- Upto 40.00 LPA

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

Total No. of Years Experience :-

Current CTC :-

Expected CTC :-

Notice Period :-

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