Manager/Asst. Manager - QA

Job Description:

Position:          Manager/Asst. Manager - QA

Location:         Silvassa

Experience:     8 - 10 YEARS

Industries:      Pharma Formulation 

Responsibilities:

• To monitor and prepare budgetary provisions for procuring new QA equipment, upgrade the facility and smooth working of the department.
• To release or reject all raw materials, intermediates, packing materials, labeling materials and finished products.
• Site Master File Updation, Validation Master Plan Updation, Quality Manual Updation.
• Handling of Market Complaints, Returns /Recall, Deviations, OOS, Validation report review.
• Vendor on site audits, Handling and Managing of audits to meet AMRI ILS requirement.
• Performing on site audits of vendors as per the requirements given by other AMRI global sites.
• To approve completed batch production and laboratory control records of critical process steps before release of the finished products for distribution.
• To review and approve all specifications, STPs, SOPs, BMR, BCR, MFR.
• To review and approve all procedures impacting the quality of raw materials, intermediates or APIs.
• To review and approve of all validation protocols and reports.
• To ensure quality related complaints are investigated and resolved in coordination with QC, QA, and production departments.
• To handle critical quality systems like deviations, change control, CAPA, training, OOS, validations and Qualifications.
• To review and approve annual product quality reviews.
• Involvement in investigations and closure of CAPA..
• Responsible for releasing or rejecting all API- s, Releasing or rejecting saleable intermediates.
• To review and approve changes that potentially impact intermediate or final product quality.
• To carryout self-inspection (internal audits) of the facility to ensure GMP systems are being adhered to.
• To coordinate with the regulatory and customers auditors for timely completion of auditing, compliance reports etc.
• To review and approve of contract laboratories, critical starting materials vendors, intermediate or APIs contract manufacturers and Quality Agreements Management.
• Preparing and implementing quality assurance policies and procedures.
• Performing routine inspections and quality tests.
• Identifying and resolving workflow and production issues.
• Ensuring that standards and safety regulations are observed.
• Addressing and discussing issues and proposed solutions with superiors.
• Documenting quality assurance activities and creating audit reports.
• Making recommendations for improvement.
• Creating training materials and operating manuals.

Required Skills

• Logical thinking.
• Organizing.
• Good in communication.

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

Salary :- Upto 12.00 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 :-