Senior Executive QA (M07) – Capsule Division

Posted time March 1, 2025 Location Boisar Job type Full-time

A. Position: Senior Executive QA (M07) – Capsule Division

Location: Tarapur MIDC, Boisar, Dist. Palghar, Maharashtra.

We have an opportunity for a dynamic and reliable individual with a passion for results. We offer stable and professional work environment.

About Custom Capsules Pvt. Ltd.
We are the Head Office & Global Manufacturing Site of Torpac Inc. of USA, a world leader in Empty Hard Gelatin Capsules for large animal health (3ml-110ml), pre-clinical studies (0.004ml to 10ml) and for use in medical devices. Our Machine Division manufactures laboratory scale Pharma machines. Over 95% of our sales are in North America, the EU & Japan. Please visit www.customcapsules.com.

As part of Torpac Inc. we have our own Sales & Distribution centers in USA and Europe. Please visit: http://www.torpac.com and www.profiller.com for details on our products.

There are ample growth opportunities for the right candidate.  We offer the personal culture of a small unit (60+ management; 200+ workmen (Permanent & Contract) with the professionalism of an international company.

Minimum Qualifications/Experience:

  1. B. Pharma, B.Sc./M.Sc. (Chemistry/Microbiology)
  2. 8 – 10 Years of experience in QA process in Pharmaceutical / food processing / cosmetics / chemical industries.

Your 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. Ensure all personnel are trained on requirements for GMP, GLP, GDP, applicable regulatory issues and other procedures related to their work area. (SBG)
  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.

D. 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).

 D2.  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

 

E. Reporting & Responsibility:

Position Reports to: Plant Head (M03)

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

Your 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.
  1. 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.

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

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.