Manager/Asst. Manager - QA
1 Nos.
82665
Full Time
8.0 Year(s) To 10.0 Year(s)
8.00 LPA TO 12.00 LPA
Production / Quality / Maintenance
Pharma/Biotech/Clinical Research
B.Pharma - Pharmacy; B.Sc - Chemistry; M.Pharma - Pharmacy; M.Sc / MS Science - Chemistry
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 :-
Key Skills :
Company Profile
Company is into quality cosmetic & pharmaceutical products manufacturing.
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- Interested candidates are requested to apply for this job.
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