Senior Executive QA

at Hunarstreet Technologies pvt ltd

Senior Executive QA

Hunarstreet Technologies pvt ltd

Company

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Senior Executive QA

at Hunarstreet Technologies pvt ltd

Agency job

via Hunarstreet Technologies pvt ltd

8 - 12 yrs

₹10L - ₹15L / yr

Mumbai, Boisar, tarapur

Skills

capsule QA

QMS

cGMP

GLP

APQR

Risk assessment

AHC

AQCS

EIA

Capexil

GMP+

FDA

BMR documents

Minimum Qualifications/Experience:

1. B. Pharma, B.Sc./M.Sc. (Chemistry/Microbiology)

2. 8+ Years of experience in QA process in Pharmaceutical / food processing / cosmetics / chemical industries.

Job Responsibilities:

C1. Principal thrust area:

You shall be responsible for maintaining and improving all QMS activity, GMP and GLP across the company.

C2. Key Deliverables:

1. Ensure manufacturing practices as per cGMP and GLP standards.

2. Handling QMS activities like change control, validations, stability, qualifications, APQR and Risk assessment etc.

3. Applications for AHC to AQCS, EIA and Capexil and coordinate related activities. (AHV/SPD: This is exclusive knowledge related to Capsule and companies manufacturing animal origin products. We have mentioned this as the candidate on joining will be responsible for this work though he/she may not be having exposure to same.)

4. Organize internal and external audits for ISO, GMP+, FDA, Capexil, GMP+, EIA and others. Maintain the documents required for those audits.

5. Organize internal and external audits for ISO, GMP+, FDA, Capexil, GMP+, EIA and others. Maintain the documents required for those audits.6. Evaluation and approval of Suppliers for RM, PM, testing labs and service providers.

7. Assisting HOD in customer complaint analysis and preparation of customer complaint report.

8. Investigation of incidents, deviations, OOS and ensure corrective actions in place.

9. Reviewing the daily availability of operators and allocating work to them.

10. Maintaining and review BMR documents, guide for relevant changes if required.

11. Label artwork review and management.

Competencies:

D1. Technical Competencies:

a) Analytical skills (spotting trends and patterns)

b) Report writing skills

c) Problem solving abilities

d) GMP and GDP knowledge

e) Good English communication skills (verbal & written).

Behavioural Competencies:

a) Quality and Service Orientation

b) Delivering consistent results

c) Ability to prioritize, organize, manage work and time.

d) Customer Centric

e) Cross Functional Team Working

Reporting & Responsibility:

Position Reports to: Plant Head (M03)

Reportees to this position: Assistant Officer QA – M12 (2 nos)

Job Location:

1. Tarapur MIDC. Tarapur MIDC, Boisar, Dist. Palghar, Maharashtra.

Preference will be given to candidates in Tarapur/Boisar area or willing to relocate.

2. For outstation bachelors, Company provides a subsidized bachelor’s flat. For outstation families, Company provides subsidized accommodation in company owned buildings. Relocation allowance is offered.

3.Tarapur- Railway station Boisar takes 1.5 hrs. by train from Borivali Station or by road via Western Express Highway.

4. Suburban local trains direct from Churchgate to Boisar Railway station available.

G. What’s in it for You:

1. Opportunity to be part of a growing organization offering niche products to Pharma industry.

2. Opportunity to work at Head Office location.

3. Intimate small company culture with MNC professionalism.

4. Company value programs TrANSSCEnD.

5. Employee events like festival celebrations, family fun events etc.

6. Five days working (alternate weeks).

7. Medical Insurance for your immediate family.

8. Housing accommodation for Bachelors & family.

Minimum Qualifications/Experience:

1. B. Pharma, B.Sc./M.Sc. (Chemistry/Microbiology)

2. 8+ Years of experience in QA process in Pharmaceutical / food processing / cosmetics / chemical industries.

Job Responsibilities:

C1. Principal thrust area:

You shall be responsible for maintaining and improving all QMS activity, GMP and GLP across the company.

C2. Key Deliverables:

1. Ensure manufacturing practices as per cGMP and GLP standards.

2. Handling QMS activities like change control, validations, stability, qualifications, APQR and Risk assessment etc.

4. Organize internal and external audits for ISO, GMP+, FDA, Capexil, GMP+, EIA and others. Maintain the documents required for those audits.

7. Assisting HOD in customer complaint analysis and preparation of customer complaint report.

8. Investigation of incidents, deviations, OOS and ensure corrective actions in place.

9. Reviewing the daily availability of operators and allocating work to them.

10. Maintaining and review BMR documents, guide for relevant changes if required.

11. Label artwork review and management.

Competencies:

D1. Technical Competencies:

a) Analytical skills (spotting trends and patterns)

b) Report writing skills

c) Problem solving abilities

d) GMP and GDP knowledge

e) Good English communication skills (verbal & written).

Behavioural Competencies:

a) Quality and Service Orientation

b) Delivering consistent results

c) Ability to prioritize, organize, manage work and time.

d) Customer Centric

e) Cross Functional Team Working

Reporting & Responsibility:

Position Reports to: Plant Head (M03)

Reportees to this position: Assistant Officer QA – M12 (2 nos)

Job Location:

1. Tarapur MIDC. Tarapur MIDC, Boisar, Dist. Palghar, Maharashtra.

Preference will be given to candidates in Tarapur/Boisar area or willing to relocate.

3.Tarapur- Railway station Boisar takes 1.5 hrs. by train from Borivali Station or by road via Western Express Highway.

4. Suburban local trains direct from Churchgate to Boisar Railway station available.

G. What’s in it for You:

1. Opportunity to be part of a growing organization offering niche products to Pharma industry.

2. Opportunity to work at Head Office location.

3. Intimate small company culture with MNC professionalism.

4. Company value programs TrANSSCEnD.

5. Employee events like festival celebrations, family fun events etc.

6. Five days working (alternate weeks).

7. Medical Insurance for your immediate family.

8. Housing accommodation for Bachelors & family.

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About Hunarstreet Technologies pvt ltd

Founded :

2022

Type :

Products & Services

Size

Stage :

Profitable

About

N/A

Company social profiles

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