QA Manager

4 days ago

Daman, Daman and Diu, India TheTalentforte Full time ₹ 8,00,000 - ₹ 9,00,000 per year

Manufacturer & Exporter of Pharmaceutical formulations, they have manufacturing facilities at Baroda, Daman in Gujarat, Vasai in Maharashtra and at Dehradun. Coral Laboratories is a public limited company listed on the Bombay Stock Exchange (BSE).

Job location: Dunetha, Nani Daman

Work timings: 9.30am to 5.30pm

Working days: Sunday

Position : QA MANAGER

Reporting to Corporate Quality Head.

Role & Responsibilities:

· To face an audits from customers and to provide compliance report.

· To ensure production and control operations are clearly defined.

· To ensure proper arrangements are in place that assure correct starting and packaging materials are used.

· To conduct periodic Product Quality Review and to ensure compliance as per the guidelines.

· To participate in the Management Review of product quality, QMS and continual improvement.

· To ensure that required, initial and Re-training is Provided and adapted according to need of factory personnel

· To monitor and control outsources activities (Eg-Outside Calibration/Outside Testing)

· To implement and maintain cGMP work environment throughout the facility

· To ensure compliance to the Quality management system. For e.g. Deviations, Change control, CAPA, OOS, OOT, Recall and market complaints etc

· To conduct Quality Risk Management, Aspect & Impact and to monitor effectiveness of mitigation plan to reduce the risk.

· To establish, implement and maintain procedure for effective monitoring and control for process performance and product quality

· Authorization of critical documents like SMF, VMP, SOP, Specification, Validation Protocol/report, BMR, BPR etc.

· To implement and maintain cGMP work environment throughout the facility.

· To review and approval validation reports.

· To ensure implementation and Monitoring of compliance with the good distribution practice requirement

· To ensure the compliance of SOPs/Protocols.

· Approval of Quality Documents and GMP Records.

· Co-ordination with internal / external customer regarding quality issues.

· To ensure the availability of quality technical agreement with different Parties.

· To participate in management review meeting and escalate the issues pertaining to quality and EHS.

· To ensure the appropriateness of document management.

· To ensure Validation / Qualification activities as per schedule are performed on time.

· To ensure self-inspection activities are performed as per schedule and to monitor effectiveness of self-inspection and compliance.

· To facilitate Quality Risk Management sessions, approval of QMR report and to take necessary actions to avoid failures in the system.

· Final review of batch manufacturing and analytical records and to prepare batch release certificate.

· Determining, negotiating and agreeing on in-house quality procedures, standards and specifications.

· Work to improve organization's efficiency and profitability by implementing production and process Excellence.

KEY SKILLS AND QUALIFICATIONS:

· Bachelor's degree in Pharmacy or Science.

· 10-15 years of experience in similar profile

· Strong knowledge of quality assurance principles, regulations, and standards.

· Excellent leadership and communication skills.

· Attention to detail and a commitment to quality.

PERKS AND BENEFITS

Salary range: Rs. 8 to 9 Lacs PA

Negotiable: Depending upon candidate & experience

If you are interested, we will need

· Updated Resume

· Current CTC

· Joining Period

Regards

Pooja Nair

Job Type: Full-time

Pay: ₹800, ₹900,000.00 per year

Work Location: In person

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